Information in English
The Swedish Act ’Biobanks in Medical Care Act‘ (SFS 2002:297) allows that human biological specimens that have been collected and/or stored within healthcare can be used for research and clinical trials if the patients/donor have given consent to this. Collection and/or use of human samples for research purposes require approval by a Swedish Ethics Review Board for each specific project/clinical trial, and the application must be submitted by a Swedish research principal. Furthermore, clinical trials for medical products must be approved by the Swedish Medical Products Agency, and a statement from the Swedish Data Inspection Board is also mandatory if the study includes certain analyses of genetic traits.
Given these preconditions, an application for access to samples from a biobank can be submitted either to
1) the head/custodian of the biobank (‘Biobanksansvarig’). For further information, se below.
2) a supraregional centre, a so called Regional Biobank Centre (‘Regionalt Biobankscentrum’). This is possible in research where more than one responsible research body participates, and where the samples are newly collected for that specific research project and are to be released to a recipient research biobank. This procedure is called the multicentre principle. For further information about the multicentre principle, se below.
1) Access to samples for research
Information and applications for research where the application is submitted to the custodian of the biobank. For contact information about specific biobanks, please contact the regional coordinators (‘Biobankssamordnare’).
This procedure is used in studies
- with only one responsible research body (single-centre studies)
- based on existing samples (single-centre or multi-centre studies)
- where samples shall not be released
Access to samples for research - Applications
2) Access to samples for research according to the multicentre principle
Information and applications for research where the application is submitted to a Regional Biobank Centre (RBC) according to the multicentre principle. For contact information click on the links RBC's respectively e-biobanks.
This procedure is used in studies with more than one responsible research body (multi-centre studies), where the samples are
- newly collected, and
- skall be released to a recipient biobank
Access to samples for research according to the multicentre principle - Applications
Links