Research Guide

In Sweden, there are 21 regions and 7 universities with medical faculties which have organized their sample collections in biobanks in various ways. The largest sample collections are the ones collected for care, diagnostics, and treatment, for example within pathology or microbiology. In addition to the biobanks of regions and universities, there are also biobanks established by private clinics, private laboratories, and pharmaceutical and medical technology companies.

Since 2003, Sweden has had a Biobank Act in place which aims to protect the integrity of sample donors in connection with the storage and use of samples taken for care or research purposes. At the same time, the Swedish Biobank Act strives to ensure the access to samples for medical research. As of July 2023, a new Biobank Act entered into force, replacing the original one. The new Biobank Act (2023:38) is applicable to identifiable* samples from living or deceased humans and fetuses, collected, stored or used for any of the purposes** mentioned in the Biobank Act, or intended to be stored for such purposes.

*Identifiable samples are samples which can be traced to the human or fetus which the sample was originally taken from.

** the purposes are 1. care, treatment or other medical purposes within healthcare, 2. research, 3. Product development, or 4. education, quality assurance or developmental work within any of the purposes mentioned as 1-3.

• Samples which are to be analysed within nine months after sampling and then destructed immediately (within 1-2 days) after analysis is completed.
• Samples used for transfusion, transplantation or IVF
• Samples which are to be physically included in pharmaceuticals or medicinal products.
• Samples collected outside of Sweden
• Samples which have been heavily modified within the framework of research or product development
• Samples that are unidentified, meaning they can no longer be traced back to the sample donor by code or similar method

Note that samples are not to be anonymised and then used for purposes which a sample donor has objected to. The Biobank Act states that samples are not to be anonymised for any use other than the ones to which the sample donor has consented, i.e., anonymisation of samples must not occur as a way to circumvent the requirements set forth in the Biobank Act.

Research Principal

The Research Principal is defined as a government agency, natural person or legal entity with an organisational responsibility to act within the entity’s own operations in which the research is carried out.

The Research Principal is ultimately responsible for submitting the application for ethical approval and for making sure that the study is carried out according to the approved plan. If there are several Research Principals, they must jointly agree to mandate one of them to make the application for ethical approval on behalf of everyone involved. The principal named as applicant is considered responsible for the study, while the others are seen as participating principals, each with responsibility for the parts of the project executed within their respective operations.

Biobank Principal

All samples which are regulated by the Swedish Biobank Act must belong to and be established in a biobank. The Biobank Principal must be a legal entity with a Swedish corporate identification number.

A Biobank Principal can, for example, be a healthcare provider/region, a university or college, a pharmaceutical company, or a government agency. An individual researcher who is not also a healthcare provider cannot be the principal of a biobank.

The principal of a biobank is responsible for ensuring that adequate resources are available for maintaining and operating the biobank in accordance with the requirements of the Biobank Act. The principal is also responsible for the processing of personal data that is carried out in connection with the handling of samples in accordance with the Biobank Act.

The principal decides if a biobank is to be established and is responsible to submit notification of the establishment to the Health and Social Care Inspectorate (IVO) as well as appointing Biobank Custodian(s).

The biobank principal for a study should be determined prior to submitting the application for ethical approval to the Swedish Ethical Review Agency, or, at the latest, before the study is initiated.

In each Swedish region, there is at least one regional biobank and an appointed Biobank Coordinator. Most Biobank Coordinators can offer guidance regarding applications during the planning of a research study, the design of research participant information, and the biobank-related parts of an application for ethical approval or a Material Transfer Agreement (MTA). In addition, Biobank Coordinators can offer guidance on where and how to get practical support regarding sampling or handling of samples.

Contact details for Biobank Coordinators

In every healthcare region, a Regional Biobank Centre (RBC) is available to help you with questions about the Swedish Biobank Act, biobank applications, and prior reviews of biobank applications. In accordance with the Swedish Biobank Act, RBC is also responsible for reviewing the biobank-related information in applications for clinical trials as well as general biobank applications.

Additionally, RBC administers the joint documentation of Biobank Sweden.

The Swedish university hospitals/universities that offer increased biobank services have Sample Service Coordinators (in Swedish: PSK). They can provide guidance and coordination when planning and starting studies that will involve sample collection at multiple sites across Sweden.

More information about the services offered by the Sample service Coordinators in relation to multi-site sampling can be found on this page under the headline: ”Operative services”.

Both operative and regulatory service is offered at different sites throughout Sweden. Our map of biobank services provides the locations and contact details for the various support functions.

Visit Map of Services

If you are uncertain about which form to use, please see our document K2.1 Form selector.

All samples that are collected in Sweden for research and are regulated by the Swedish Biobank Act must belong to a Swedish biobank registered at The Health and Social Care Inspectorate (IVO).

This means that:

• Newly collected samples for research – need to be established in a biobank.
• Existing samples requested to be used for research – must be established as a new sample collection in a biobank, provided that access to the samples is granted.  

To establish a sample collection in a biobank, use form L1.1. If the principal (in Sweden) you belong to does not have a biobank of its own, the sample collection can be established in another principal’s biobank — for example, a regional biobank — subject to an agreement.

In case of uncertainty regarding the principal or biobank under which to establish your sample collection, contact the Biobank Coordinator in the region or regions where sampling is planned to take place.

Instructions for how to complete document L1.1 can be found in our document K4.

This form is used when applying for the release of existing samples from a biobank.

Upon release, samples cease to be part of the biobank from which they were released. Responsibility and the right to use said samples are transferred to the recipient’s biobank. Samples may only be released to a biobank in Sweden and only after a request from the recipient.

Instructions on how to complete the form L1.2 can be found in the document K4.

These appendices are used when you want to gain access to samples already stored in biobanks, i.e., existing samples. Depending on the structure of the study and the character of the samples, several appendices may be relevant for one and the same biobank agreement.

For research collaborations, it is important that the responsible Research Principal is clearly specified; as this is not regulated in the Swedish Biobank Act, it must be determined through agreement or understanding between the different Research Principals involved.

This form is used to inform the region where new research samples are collected that it will not be the responsible biobank for said samples, and that the samples will instead be established in the biobank of another principal.

The form shall be signed by the responsible biobank and sent to the biobank in the region where samples are to be collected before sampling commences. If samples are collected across several regions, form L7 needs to be sent to all those regions.

If a region is responsible for samples, there are standardised agreement templates for sending samples for an action (so-called MTA, see below). There are no restrictions preventing universities, colleges, or other legal entities from using these templates. However, if any changes are made to a template, the logotype of Biobank Sweden is to be removed.

The agreement templates apply to samples and related sample data (sample code). They do not apply to other data regarding the study.

There are three different variants of MTA. Which template to use depends on who the Research Principal is and if there is a commercial/non-commercial Sponsor (a person, company, institution, or organisation responsible for initiating, leading and managing the funding of a clinical trial/performance study).

L2a1. AGREEMENT about making Human Biological Material available to a Research Principal for an Action

This template is used when a region (or a university) is the principal of the biobank and another region (or university) is the Research Principal (the one requesting the action).

L2a2. AGREEMENT about making Human Biological Material available for an Action in clinical trials and performance studies

This template can be used when a region is principal of the biobank and there is a commercial/non-commercial Sponsor with overall responsibility for implementing the study.

L2a3. AGREEMENT about making Human Biological Material available when a Research Principal sends samples for an Action to a Recipient

This template is used when the Research Principal is the same as the principal of the biobank.

For more information about MTA, see document K5. For more information regarding which parties should sign the respective agreements, see appendix K5a. Signering av MTA och avtal med Tredje man. (Swedish only)

In cases when the recipient is to be considered a Personal Data Processor, a Data Processing Agreement according to GDPR must be drawn up with the recipient. The Biobank Principal and/or the Research Principal often have their own agreement templates that should be used for Data Processing Agreements.

Keep in mind that support and legal guidance should be provided by the Research Principal.

The Swedish Association of Local Authorities and Regions, SALAR (in Swedish: SKR), has gathered information and developed agreement templates in both Swedish and English for a Data Processing Agreement that is compliant with article 28 of the GDPR.

A Data Transfer Agreement (DTA) might be needed in cases where the recipient is an independent personal data controller and information is released to said recipient.

Information regarding personal data control can be found in several places, including the website of the Swedish Authority for Privacy Protection (imy.se/en) which also contains information to researchers regarding the processing of personal data. Biobank Sweden also suggests that you contact your local organisation for support in these matters.

Besides an agreement regarding the establishment of a sample collection, an agreement for release, and an application regarding existing samples, additional agreements might be needed regarding specific types of operative services offered by the biobank, such as storage, release, sample handling, sampling, etc.

Services and agreement forms offered may vary between different biobanks.

If you wish to know more about operative agreements and services, contact a Biobank Coordinator or a university hospital/university that offers operative biobank services. Contact details can, for example, be found in our map of biobank services.

Visit our map of biobank services

In general, it is good to include the following in the research participant information regarding samples and biobanking:

• The types and volumes of samples taken, and how often sampling will occur
• Who is responsible for samples
• If samples are to be sent for an action, e.g., analysis or storage (within or outside of the EU/EES)
• That consent can be withdrawn, leading to the destruction of one’s samples, and how to go about it
• That samples are coded and handled according to the Swedish Biobank Act (2023:38)
• The analyses (e.g., genetic analyses) that will be carried out
• If the study wishes to store samples for future research, specific information is required

Through their biobank coordinators, most regions offer support with the design and prior review of the biobank parts of the research participant information.

Contact the local biobank coordinator in the region which your biobank application covers.

Contact information – Biobank Coordinators

At any given time, the sample donor has the right to withdraw their consent for stored samples. This also includes samples stored before the Swedish Biobank Act came into force.

If the withdrawal regards all type of use, the sample is to be destroyed immediately or as fast as possible.

Samples may only be anonymised if it is not possible to destroy a sample without risking to potentially destroying other samples in the process.

The donor’s right to withdraw their consent requires that every single sample regulated by the Swedish Biobank Act must be traceable.  

Samples collected for a research study can be of great value for future research that is yet to be planned. Therefore, in some cases, it might be relevant to ask for consent to store samples for future research and follow-up studies.

Please note, approval from the Swedish Ethical Review Authority or the Ethics Review Appeals Board is always required before stored samples may be used in new research studies.

The Swedish Ethical Review Authority or the Ethics Review Appeals Board is also responsible for deciding whether a potential new study needs to collect consent from participants, or if the study can use the consent already collected as part of the first/former study.

Before signing a biobank agreement and gaining access to samples regulated by the Swedish Biobank Act, an ethical approval by the Swedish Ethical Review Authority is required.

For an ethical approval to be valid, research must start within 2 years from the first approval.

Below we have listed some of the most central parts regarding biobanking that needs to be included in your application for ethical approval:

• The Research Principal needs to be the same in both the application for ethical approval and the biobank application
• The Research Principals for the participating sites of the study need to be specified
• Which sample types are to be collected
• Which sample volumes and how often sampling is planned to occur
• Which analyses are planned
• If samples are to be sent within or outside of the EU/EES for an action
• What happens with the samples after the study is finished
• If samples are to be stored for future research
• How samples are coded and how the code key is stored
• How personal data is handled and stored
• Start and end date of the study

Most regions’ Biobank Coordinators offer the service of reviewing the biobank-related parts of the application for ethical approval and the biobank-related information prior to their submittal to the Swedish Ethical Review Authority. Biobank Coordinators can also provide support and advice on how to design them. This service is offered to facilitate and shorten the time of processing at a later stage, as well as reducing the need for requests of amendment for previously approved ethical applications.

If your application regards one of the regional biobanks, you can contact the biobank coordinator of the region which is the principal for the study for more information and guidance.

Information about the application for ethical approval and how it should be submitted can be found at the website of the Swedish Ethical Review Authority.

Tip! The Swedish Ethical Review Authority has produced some training material that can be found on their website called ‘Guide to the ethical review of research’.

Collection service

At several sites in Sweden, there are functions for guidance and practical support relating to sampling and sample handling.

On sites where operative biobank service is offered, several sample types can be collected. The most common liquid-based sample types are serum, plasma, and urine. However, handling of several other sample types, such as PBMC and cell-free plasma, is available at some biobanks.

Operative biobank service includes ordering of samples, sample handling, centrifugation, aliquotation, IT support and coding, as well as storage of samples. Sample handling is done according to the biobanks’ established protocols in a standardised process ensuring high quality, safe storage with temperature surveillance, and full traceability of samples.  

The model of Healthcare Integrated Biobanking (SIB) was created as part of a project aiming to establish sampling and sample handling for research through the current processes already in place within routine healthcare.

If you are interested in learning more about operative biobanking service in a particular Swedish region, contact the local biobank for guidance, service information, and pricing.

Visit Biobank Sweden’s contact page

Biobank Sweden has Sample Service Coordinators with broad expertise and well-established networks within the biobank sector. Their job is to support researchers who plan to either collect or use biobank samples in more than one region in Sweden.

By means of their comprehensive knowledge about the procedures, offerings and sample and data formats of various biobank facilities, the Sample Service Coordinators can guide researchers through the often complex planning stages.

If you are interested in operative sampling service at several different Swedish regions, contact a local Sample Service Coordinator for guidance and information regarding available services and pricing. Contact information can be found here:

Map of Services

Sample collection through local biobank facilities will be carried out in accordance with the existing procedures and procurement contracts of the local principal. This entails that the types of tubes used for collection and storage of samples, as well as the sample handling procedures, may differ between biobanks. Normally this has no impact on sample quality or usage, but the storage format does matter when samples are retrieved to be used; for more information, see our headline Retrieval.

Alternatively, it is possible to conduct country-wide sample collection through the supervision of a single biobank facility. This can, however, aggravate the impact on sample quality and limit future use. For some research projects, this can still be the best option.

Contact the Sample Service Coordinator or the local biobank for advice regarding the type of sample handling.

Storage of samples can be implemented in many ways:

Storing with traceability

Samples are collected through the local biobank’s operative biobank service. Samples are stored in the biobank’s freezers and the biobank is responsible for the traceability of the samples. Retrieval of samples is made by the biobank.

Renting storage space in a freezer

Boxes of samples are stored in the biobank’s freezers. The researcher is responsible for ensuring the traceability of the samples. The biobank hands out boxes, but no retrievals of samples are made from the boxes.

Freezer hotel

Researchers can rent storage space for a freezer of their own in a room adjusted for freezers. The researcher has the responsibility for ensuring the traceability of the samples and has personal access to the freezer.

Contact the local biobank for more information regarding the different storage options. If samples are stored at another principal, then an agreement for storage of biological samples is required.

Retrieval means that samples are picked out of a freezer or other type of storage to perform an analysis or other actions. When samples have been collected via the biobanks operative biobank service and are stored in the biobanks’ freezers, the retrieval of samples follows an established protocol. Make sure to contact the biobank where samples are stored at an early stage for advice, guidance, and prices.

For more information about the agreements needed:

Biobank agreement and MTA

National retrieval coordination

When retrieving samples distributed across several Swedish biobanks, Biobank Sweden offers support for coordinating the retrieval. National retrievals are complicated, as requests for retrievals may involve different principals with different local conditions, tube formats, IT systems, etc. A retrieval often requires the coordination of several different main actors: the biobanks, the researchers/research project, and the analysing laboratory/laboratories.

Some laboratories have the capacity to manage different tube formats, but not all of them; thus, the need may arise to contract an additional actor to reformat and sometimes also randomise samples from all the involved biobanks into a uniform format. Contact the local biobank for information regarding the possibilities regarding reformating.

Visit Biobank Sweden’s Map of Services

To manage the retrievals as smoothly as possible, the different actors need to be involved in the coordination process. Biobank Sweden is represented by a National Retrieval Coordinator, and the research project, the analysing party and any additional actors involved all need their own respective representatives as well. Questions that need to be solved are:

• Timetable for the analyses
• Specifics regarding the samples to be analysed, e.g., sample types, volumes, tube formats, and, if applicable, requirements regarding sample quality
• Decision from the researchers regarding which sample donors/samples are to be included, inclusion/exclusion criteria, time of sampling etc.
• Timetable for the work carried out by the biobanks
• Agreements needed (such as biobank agreement, retrieval order, MTA)
• What information needs to be transferred and how
• Funding
• Sample logistics/transport
• Potential reformatting, DNA-extraction, pooling, or other type of sample handling

Some biobanks offer additional services besides sampling, storing and retrieval/withdrawal. The range varies between different biobanks but in the list below you can see some examples:

• Creation of paper referrals for sample collection
• Renting of storage space for biobank samples in a freezer of your own or room for boxes in the biobanks’ low temperature freezers
• IT-support for traceability and sample information etc.
• Reformatting of samples during retrieval (reformatting means that samples are transferred to a different tube type or that aliquotation of the sample is made, for example when only a partial volume of the sample is needed for an analysis)
• DNA extraction from sample types such as whole blood and saliva

If you are interested in any of the services above, contact the local biobank for counseling, pricing information and other guidance.