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Research biobanks

A biobank is a “filing system”

In terms of the Act on Processing of Personal Data, a biobank is understood as a structured collection of human biological material, which is accessible according to certain criteria and in which information contained within the biological material can be linked to individual persons.

A biobank for research purposes is often called a research biobank.

A biobank can be subject to the Act on Processing of Personal Data

A biobank meets the Act on Processing of Personal Data’s definition of a filing system and is thus subject to the Act on Processing of Personal Data, cf. section 1(1) of the act.

Biological material collected for scientific purposes comprises a biobank if the material (samples) is stored for a longer period of time than it takes to collect and analyse the samples. Samples that are destroyed immediately after the completion of analysis are not considered biobanks.

The processing of biological material that does not comprise a biobank is also covered by the Act on Processing of Personal Data if the material is used in a “private” research project (i.e. notification is submitted by a private controller). If the controller is a public authority, the material is not subject to the act.

Notifying the Danish Data Protection Agency

The establishment and use of a biobank requires a notification to, and authorisation from, the Danish Data Protection Agency. A biobank must be reported in writing together with the notification on the specific project / scientific purpose for which the material is to be collected and used. The Danish Data Protection Agency’s authorisation must be received prior to the commencement of collection of the material.

Sensitive personal data

Biological material contains sensitive personal data, which can be identified and described using various techniques. Biological material also contains more data than the data to be used in the research being conducted. This makes it very important to protect biological material. Material in a biobank must always be processed and stored with this in mind.

About storage and protection

Storage of biological material often requires special technical measures. Material in a biobank must therefore be stored in a technically defensible manner that ensures the material is not accidentally or illegally destroyed, lost or damaged. It is also necessary to ensure that the material does not become known to unauthorised parties nor is otherwise abused or used in violation of the legislation. Therefore, the researcher is required by the Danish Data Protection Agency to produce special guidelines for the storage and use of the project’s biological material.

 
A research biobank must have a defined purpose

It is in violation of the Act on Processing of Personal Data to collect biological material for research purposes unless the collection is performed for a specifically defined scientific purpose. The Danish Data Protection Agency cannot provide authorisation to create a biobank without a clear and defined purpose.

Destruction or anonymisation

When the research project is completed (or material is no longer to be used for scientific purposes), the biobank’s material must be destroyed or anonymised. Anonymous biological material may continue to be stored and used without further authorisation from the Danish Data Protection Agency.

Disclosure of biological material

The disclosure of biological material for use in other scientific projects may only be carried out with special authorisation from the Danish Data Protection Agency. This also applies if the entire biobank is to be transferred to another researcher or is to be used for another scientific purpose.