Biobank research

Every year, a large number of samples of identifiable human biological material is put into biobanks. How these samples may be collected, stored and used is regulated by the Biobank Act. On 1 July 2023, Sweden’s new Biobank Act came into force. The rules within it apply both to newly collected samples and those that had been collected before the law entered into force.
 
The purpose of the Biobank Act is to encourage respect for the integrity of the individual. The act includes rules about consent and ensuring that samples are stored in such a way that unauthorised access is not granted. It is also important that the samples are stored in such a way that they do not risk being destroyed in error.

Read more about the changes on Biobank Sweden’s website

Note that research on samples covered by the exemption must undergo ethical review before being carried out.

Read more about ethical review here

Which samples are covered by the law?

The Biobank Act applies to identifiable human biological samples. Exemptions apply to samples analysed within nine months of their collection and then destroyed immediately after the analysis. The Act will, however, be applied to a sample if it is intended that the sample be stored for more than nine months, or if the sample is not immediately destroyed after having been analysed.

Consent

In order for a sample to be collected and then stored in a biobank, the person providing the sample must have given their consent. When it comes to children who cannot yet provide consent, special rules apply. Exemption from the consent rule must have a legal basis. 
 
Before consent is given for a sample to be taken and stored in a biobank, the person providing the sample is to have received information about the purpose of collecting and storing the sample, what the sample may be used for, as well as what uses are allowed by law. The person providing the sample is to be informed of their right to revoke or restrict consent for the collection, storage or usage of a sample in a biobank.
 
Consent may be revoked at any time. If the revocation concerns the storage of the sample or all use of the sample, the sample is to be destroyed immediately. Should it be impossible to destroy the sample without other samples being destroyed, the sample must immediately be de-identified. The person providing the sample may also give notice at any time that the sample may not be used for one or more purposes. This is to be documented.