Access a biobank in Sweden
Overview of access rules in Sweden
A prerequisite for samples to be used in research is an approval from the Ethics Review Authority according to Act (2003:460) concerning the Ethical Review of Research Involving Humans. Samples covered by the Biobank Act must be set up in a sample collection in a biobank with a biobank custodian appointed by the principal for the biobank. It is the biobank custodian who approves the application for access to samples. In order to gain access to samples that are included in existing research sample collections or cohorts, consent must also be obtained from the group or committee that grants access to the respective sample collection.
According to the Swedish Biobank Act, Swedish biobank samples may not be stored long-term abroad and can only be released to a biobank registered in Sweden. However, samples may, for certain purposes and under specific conditions, be sent for analysis abroad If samples are to be sent for analysis abroad, the biobank custodian must establish the terms that the samples are to be returned or destroyed when they are no longer needed for the purpose for which they were sent.
In order to facilitate the requirements of the Biobank Act, Biobank Sweden has common principles and agreements for access to samples for research:
This guide summarizes the process of gaining access to biological material and data from Swedish Biobanks:
1. Identify biobank with the required sample collection.
– For more detailed information, visit the respective biobank web site.
2. Apply for approval from The Swedish Ethical Review Authority.
3. Submit application form to respective biobank.
– Use the correct application form. Application forms and Instructions can be found at biobanksverige.se
– Include a copy of signed ethical review application, decision of an Ethical Review Authority, Information for patient/research participants with the informed consent.
– For single-centre studies or studies including existing samples, use Application form L1 – access to test samples for research
– The following appendices may also be required:
- L1a – if the application involves tissue samples.
- L1b – if the application involves fluid samples.
- L1c – if the application involves PKU samples.
– For multicentre studies involving newly collected biobank samples where the sample collection will be released to a recipient biobank. Complete application form N1a and submit to the Regional Biobank Centre (RBC) in the region where the research principal responsible is located.
4. Application assessed.
5. Terms of delivery & service agreed & contract signed.
– This will vary according to the biobank and nature of the project.
6. Samples / data retrieved & dispatched.
– According to agreement in contract.
Access to biological samples is mainly regulated by these laws:
The Biobank in the Medical Care Act (2002:297) regulates how human biological material, with respect for the individual’s integrity, can be collected stored and used for care and treatment, quality assurance, development, education and research.
Read more (.pdf)
The Act concerning the Ethical Review of Research Involving Humans (2006:460)
regulates how samples may be used in research
Read more (in Swedish)
General Data Protection Regulation (GDPR)
Publicity and Secrecy Act (2009: 400)
determine how the information can be disclosed.
Read more (in Swedish)
The Patient Data Act (2008: 355)
regulates information about samples in the medical record.
The "Registers and Biobanks in Transition” strategic initiative is funded by EIT Health