A new biobank act

On July 1, 2023, a new Swedish Biobank Act came into effect, representing a modernization of the current law. The intent remains the same, to regulate how identifiable human biological material should be collected, stored and used for ethically approved purposes, but various aspects have been updated to remove ambiguities that left uncertainty in interpretation of the original law which dates back to 2003.

On the 25th of January 2023 Sweden's Riksdag paved the way for the updated new biobank law, providing greater clarity and better prerequisites for medical research while ensuring the integrity and rights of sample donors. KI Biobank is well-prepared for this, with information and guidance for researchers, students and information that can help with questions from sample donors, study participants and the public.

The most important changes are

  • A shift of emphasis from where the samples are collected to what the purpose of collection is.
  • The current distinction between primary and secondary sample collections has disappeared, as it has proven confusing and an administrative burden.
  • When samples are collected for research purposes, the legal entity can be the research biobank directly, even if sample collection takes place within healthcare.
  • Samples may only be collected within legal entities, and can be transferred between different legal entities more easily and clearly.
  • Samples can also be stored overseas, long term, if required for the purpose of the research.

 

Contact KI Biobank for more information or requests for a lecture on the new biobank act.

AA
Content reviewer:
28-10-2023