6. Biological Specimen

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

The Federal Government’s export control policy is administered by the Federal Office for Economic Affairs and Export Control. Dual-use items, which are those that may be used for civil and military purposes, are subject to controls. The Federal Office for Economic Affairs and Export Control decides on the granting or refusal of an authorization after taking into consideration all the available information about the intended use.

It is noted that the science and research sectors are subject to the same export controls as other sectors. The Federal Office for Economic Affairs and Export Control has published guidance entitled “Export Control in Science & Research” (available via the link below) which states that “control regulations equally apply to private individuals such as scientists, but also to legal entities such as research institutions or developing and manufacturing companies - regardless of the motivation and purpose of their activity. The objective potential for misuse is the sole criterion”.

Forms and contact details to establish whether a license may be granted are available at BAFA.

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 ICF template model available on the AKEK website provides specific language for biospecimen collection.

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.