Biobank

The Swedish Act “Biobanks in Medical Care (SFS 2002:297)” applies for human tissue or cell samples if they are taken within healthcare and stored for longer than two months, including also samples collected for research purpose in the healthcare system stored for more than six months (OBS from 1 Jan. 2019). The purpose of the biobank act is to protect patient and/or donor’s integrity and rights meanwhile allowing samples to be used in research and clinical trials. It also requires full traciability of all samples collected within healthcare and therefore must be registered in a biobank.

English information at Biobank Sverige

To start a sample collection or gain access to existing biobank samples, you need:

• An agreement with a biobank
• An approval by a Swedish Ethics Review Board (ERB)
• Patient/donor’s consent (unless the ERB has granted exemption)

Clinical trials for medical products must also be permitted by the Swedish Medical Products Agency.

You are welcome to contact us at Biobank Core Facility for further assistance.

Access to samples for research, Biobank Sweden

Existing sample collection

Samples collected within healthcare are usually taken for care purposes. These samples belong to the healthcare biobank and comprise a primary sample collection. Gaining access to these requires a decision from the biobank custodian, who shall ensure that sufficient material remains for the patient’s care and treatment. Note, biopsy-tissue/cytology samples passing through pathology department is also considered as an existing sample collection, regardless if samples are collected for the ongoing specific research project.

Newly collected samples

Samples collected for a specific research project. Note that newly collected samples in the healthcare principal’s area of responsibility must be registered within a healthcare principle’s biobank. The sample collection can be released to a research principle’s biobank and comprise a secondary sample collection.

Newly collected or existing samples, Biobank Väst (Swedish)

Within Västra Götaland, the biobank application is sent together with the documents needed to Biobank väst.

Biobank application in Västra Götaland (Swedish)

More information

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

For access to the newly collected samples and multicenter studies of existing samples (single-centre studies), the application form "L1, Access to sample collection and personal data for research" shall be completed. For access to existing sample collection, following appendix can be attached:

• L1a, if the application is concerning existing biopsy-tissue/cytology samples
• L1b, if the application is concerning existing liquid-based samples
• L1c, if the application is concerning existing samples in PKU biobank

Note: A sample collection can remain within the healthcare principle’s biobank or released to research principle or another designated biobank.

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 both "N1a Appendix A” (Sweden’s County councils and regions involved in the study) and "N1b Appendix B" (investigators involved in the study).

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

For more detailed instruction concerning single-centre and/or multicentre studies and application forms, please visit Biobank Sweden.

In the Västra Götaland County, the biobank application is approved by the Regional Biobank centre, a unit under Biobank West, with registration number 890 in records of the Health and Social Care Inspectorate (IVO). Please attach the documents in an email to rbcvast@vgregion.se

Send your original documents to following address:
Sahlgrenska University Hospital
Biobank West/Regionalt biobankscentrum
413 45 Gothenburg

Samples within the scope of the study can be sent for analysis for certain purposes to another unit for research or to a university or to another contracted company domestically or abroad without it being considered to be a matter of extradition release. A Material Transfer Agreement (MTA) shall be established with the host laboratory and following terms must be observed:

• The healthcare principal’s biobank custodian must have continued responsibility for the samples
• The samples must be pseudonymised(coded)
• Personal data may not be sent in the same parcel as the samples
• Consent must exist
• The samples are returned to the healthcare principal’s biobank or destroyed after the analysis is completed.

For more detailed instruction concerning Material Transfer Agreement (MTA) and application form, please visit Biobank Sweden.

In the Västra Götaland County, the MTA is approved by Regional Biobank centre, a unit under Biobank West. Please attach the document in an email to rbcvast@vgregion.se

Send your original documents to following address:
Sahlgrenska University Hospital
Biobank West/Regionalt biobankscentrum
413 45 Gothenburg