LEGISLATION. As of July 1, 2023, Sweden implemented a new Biobank Act (2023:38). The act covers identifiable human biological samples and regulates how biobank samples may be collected, preserved, and used. The act also applies retroactively to samples collected in the past. All samples falling under the act must be registered in a biobank.
Given the new legal framework, Gothenburg University (GU), in collaboration with Biobank West in Region Västra Götaland (VGR), will conduct an impact assessment regarding within which organization (VGR/GU) a future biobank for research sample collections should be organized. This work includes a review of the affected work processes and a cross-GU inventory of existing sample collections/biobanks for further processing. Until a decision has been made, new sample collections will continue to be registered in Biobank West within VGR.
The Biobank Act is designed to protect the rights of the sample donors and enhance their privacy at collection, preservation, and use of biobank samples. At the same time, the act aims to enable the use of samples for purposes such as healthcare and research to improve and advance medical care through access to samples for medical research.
According to the Biobank Act, samples in a biobank may be used for various purposes, including healthcare and treatment, as well as education and research. In the new Biobank Act, the purpose determines when the act is applicable, which means that samples collected outside a healthcare provider’s activities are also covered.
The general rule is that an ethical review and approval is required to collect, use, and preserve samples for research purposes. Information to sample donors and the obtaining of consent for research on biobank samples are regulated, as before, by the Ethical Review Act (2003:460). According to the new act, samples collected in healthcare can be saved in a biobank if the patient/sample donor consents to healthcare and has received information in accordance with the requirements of the Biobank Act. The previous distinction between primary and secondary biobanks is removed. The act does not specify who should be the biobank principal in a particular collaboration. In cases where samples are collected for research purposes, the research principal can be the biobank principal, even if sample collection is performed within healthcare.
For more information about the new Biobank Act:
For inquiries about the work, please contact
- Elin Stenfeldt (elin.stenfeldt@gu.se), National sample service coordinator at Core Facilities
- Åsa Torinsson Naluai (asa@clingen.gu.se), University’s biobank coordinator at Core Facilities
BY: ELIN STENFELDT
