Research

Find out how to access samples in Swedish biobanks for research, method development or clinical trials. This includes information regarding the different application processes and some of the services which you can use as a researcher.

Access to samples

The Swedish Biobanks in Medical Care Act (SFS 2002:297) allows human biological material that have been collected and/or stored for healthcare purposes to be used in research and clinical trials if the patient/donor has given consent. 

To start a sample collection or gain access to existing biobank samples, an agreement with a biobank and an approval by the Swedish Ethical Review Authority is required. Clinical trials for medical products must also be approved by the Swedish Medical Products Agency.

Documents, Application Forms and Instructions on how to access biobanks samples and complete an application can be found at our documents page.

For information regarding how to access samples for clinical trials, please see our clinical trials information page.  

New Biobank Act on July 1

The Swedish Biobanks in Medical Care Act will be replaced by a new Swedish Biobank Act, effective July 1, 2023.

Learn more about the new legislation 

Application procedures

A biobank application is always required for using biobank samples for research purposes. The application procedure may differ depending on your study design and sample collection. 

Application forms to use:

Single-centre studies:

To apply for access to newly collected samples and/or existing samples, use form: L1. Access to sample collection and personal data for research

Please note that a sample collection can remain within the healthcare principal’s biobank or be released to a research principle or another designated biobank.

Multicentre studies:

For access to newly collected samples in multicentre studies where the sample collection will be released to a recipient biobank, following application form N1a. Access to newly collected biobank samples and associated personal data in multicentre studies,  shall be completed, enclosed with N1b. Appendix (information about samples, number of individuals, regions and researchers/investigators)

Please note that the multicentre principle cannot be applied if only private healthcare providers are in the study. At least one region must take part in the study when using the multicentre principle.

For more detailed instructions concerning multicentre studies, please see: M3. Instruction to MC N1a

Appendix that may have to be included with the application:

– L1a, if the application is concerning existing biopsy-tissue/cytology samples
– L1b, if the application is concerning existing liquid-based samples
– L1c (only in Swedish), if the application is concerning existing samples in the PKU biobank

Material Transfer Agreement (MTA)

If human biological material (samples) shall be sent for analysis/analysis outside of the Biobank Principal, while the responsibility of the sample remains, an agreement that regulates how the sample are to be handled shall be established with the Recipient. The agreement regulates the conditions under which the sample are to be obtained and used, as well as how the sample is to be handled when it is of no use for the purpose in which it was sent. If a region is the Biobank Principal, standardized agreement templates for the transfer of material (i.e. MTA) are used. 

L2a1. AGREEMENT on the Transfer of Human Biological Material to a Research Principal

L2a2. AGREEMENT on the Transfer of Human Biological Material in case of a Sponsor

L2a3. AGREEMENT on the Transfer of Human Biological Material when the Research Principal is the same as the Biobank Principal

For more detailed instructions concerning material transfer agreements, please see K5. MTA information 

Support services

There are several services which you can use as a researcher to get the support you need regarding access to biobank samples in Swedish biobanks. Click the toggle menus below to find out more.

Useful resources

• Guide to biobanks in Sweden – This document describes biobanks in Sweden and provides guidance on what researchers and companies should do to get access to existing samples in Swedish biobanks, as well as requirements for collecting new samples from persons in Sweden.
• Biobank Sweden’s glossary – is one of the principal documents to obtain a uniform, nationwide interpretation of the Biobanks in Medical Care act and to create common procedures. The glossary is maintained and updated by Biobank Sweden and contains terminology concerning biobank samples and guidelines on how to utilise the samples in healthcare and research.
• National registers and Quality registers – See our summary of the Swedish national registers and quality registers
• BBMRI-ERIC Directory – is a tool that collects and makes information about biobanks and research sample collections, open for collaborations, available. Biobank Sweden is the Swedish node for BBMRI-ERIC Directory.