Citizen Info

As a central laboratory for the Danish healthcare system SSI carries out specifik analyses and therefore receives samples from general practitioners and hospitals for analysis with the purpose of diagnosis.
Any surplus sample material is stored in the Danish National Biobank, which is part of SSI. This is done so that a new analysis can be performed if your doctor, together with SSI, assesses that a second analysis is necessary in order to diagnose you. Your doctor will be able to inform you whether the sample was analyzed by SSI. You can also find this information yourself by logging in and viewing the details for each test result at sundhed.dk.

Samples may also come from voluntary participation in a specific research project, where you have voluntarily chosen to provide biological material for future research at SSI, for example through participation in the Danish National Birth Cohort (Bedre Sundhed i Generationer).

In addition, the Danish National Biobank stores samples on behalf of other data controllers. In such cases SSI only acts as a provider of freezer capacity.

SSI is assigned a number of statutory tasks under Section 222 of the Danish Health Act, including diagnostics, prevention, and control of infectious diseases, as well as other tasks for the benefit of public health. In order to carry out these tasks, it is necessary for SSI to process personal data (both samples and information about samples). SSI’s tasks are described in Section 222 of the Danish Health Act.

SSI processes personal data on the basis of Article 6(1)(e) of the General Data Protection Regulation (GDPR), in conjunction with Section 222 of the Danish Health Act, as the processing is necessary for the performance of a task carried out in the public interest and as part of the exercise of official authority assigned to SSI.

The processing of special categories of personal data also takes place on the basis of Section 7(3) of the Danish Data Protection Act, as well as Article 9(2)(g), (h), and (i) of the GDPR and Section 222 of the Danish Health Act, as it is necessary to process the data for the purposes of preventive disease control and medical diagnosis, as well as for reasons of public interest in the field of public health.

SSI processes civil registration numbers (CPR numbers) under Section 11(1) of the Danish Data Protection Act, as the processing is necessary to uniquely identify the individual from whom the sample was taken.

When residual material is disclosed or reused in research projects, this will typically take place under Section 10(1) of the Danish Data Protection Act. In such cases, the data may not subsequently be used for purposes other than scientific and statistical ones, cf. Section 10(2) of the Danish Data Protection Act.

The Danish National Biobank stores a large number of samples for several different purposes. 

Residual biological material from a sample analyzed by SSI as a central laboratory will be stored for the purpose of your treatment. For example, your doctor may determine that it is necessary for SSI to perform a new analysis of your sample in order to diagnose you. In this case, SSI will not analyze or examine your human DNA, but only viruses or microorganisms present in the sample.

In addition, SSI may use the samples in its efforts to combat infectious diseases. Under Section 222 of the Danish Health Act, SSI has the task of preventing and combating infectious diseases, for which purpose SSI may need to analyze viruses or microorganisms in the samples. This enables SSI, for example, to adjust a PCR test so that it can detect new COVID-19 variants, or to investigate when a serious outbreak of an infectious disease began. In these cases as well, SSI will not analyze or examine human DNA, but only viruses or microorganisms present in the samples.

The samples may also, under certain conditions, be used for specific research projects. This requires that the person from whom the biological material was taken is not registered in the Tissue Utilization Register (Vævsanvendelsesregistret). In addition, a specific research project must be approved by a research ethics committee. If the research project is not carried out by SSI, the disclosure of residual material to the external researcher must also be approved by the Danish Data Protection Agency (Datatilsynet). Afterwards, the Biobank’s Advisory Board decides whether biological material can be provided for the specific research project.

Read more here: Link til rammer

If SSI stores samples from you in the Danish National Biobank, you have a number of fundamental rights under the rules on the processing of personal data. Among other things, you have the right to know which samples from you SSI stores, and you may request that your samples be destroyed.

You can read more below about how to exercise your rights. You can also read more about SSI’s processing of personal data here: Information about processing of personal data

If you do not want your samples to be used for research, you can register in the Tissue Utilization Register (Vævsanvendelsesregistret).

Read more on the Danish Health Data Authority’s website: Use of biological material and genetic information (in Danish only)

In the future, you will be notified whenever we receive a new sample from you for analysis. If samples from you are stored in the Danish National Biobank, you will receive a letter from us. You may already have received it. You can also view the letter here: Link

If you would like to know which samples from you may be stored in the Danish National Biobank, you can request access by contacting 'SSI Data Protection and Information Security' via e-Boks or Digital Post. 

See guide: Secure communication with SSI

You may also send physical mail to:
Statens Serum Institut
Artillerivej 5

2300 Copenhagen S  

Biological residual material contains human tissue. When analyzing human tissue, personal data about the individual from whom the sample originates may be derived. This may include, for example, information about health, ethnicity, etc. We process a range of supplementary information along with the sample, e.g. whether the sample is blood, saliva, etc., and where it comes from. In addition, we process general information about you, such as your name, your civil registration number (CPR), etc.

SSI also maintains a register called the Danish National Biobank Register, which makes it possible to link biological samples with data from various Danish registers for research purposes. Information from registers include e.g. data from the Central Person Register about gender, date of birth, nationality, etc., as well as information from the National Patient Register with hospital-related data such as date and time of admission and discharge, treatment, diagnosis, surgery, etc.

If you have been in contact with SSI, or if the performance of one of SSI’s statutory tasks has made it necessary, we process personal data about you. You can learn more about this here: Information on Statens Serum Institut’s processing of personal data. Information about processing of personal data.

You have the right to decide that samples taken from you in connection with treatment in the healthcare system must not be used for research. This registration applies to all samples from you, including those that may be stored in other biobanks in Denmark. You must record your decision in the Tissue Utilisation Register (Vævsanvendelsesregisteret).

If you register in the Tissue Utilization Register, samples from you cannot be made available for research projects from the time of your registration onwards.

Read more on the Danish Health Data Authority’s website: Use of biological material and genetic information (in Danish only)

 

You can request the destruction of samples from you that are stored in the Danish National Biobank. Please note that destroyed samples cannot be recreated. Certain samples may contain information about you that could be crucial for later diagnosis and treatment, for example samples taken in connection with newborn screening (also called PKU samples).

 

If you have specific questions about PKU samples, you are welcome to contact SSI’s Department of Congenital Disorders at tel. no. 3268 8420 or by email at sikkerpost-ms@ssi.dk

If you wish to have your biological samples destroyed, you can submit a request for destruction directly to the biobank via E-boks or borger.dk: Write directly to the Danish National Biobank.

For other inquiries, you can send an email to the Department of Data Protection and Information Security at ssidatabeskyttelse@ssi.dk

Biological material may, under certain conditions, be used for specific research projects at SSI or at other research institutions. As a rule, you have the right to access the information that SSI processes about you, but there are a number of exceptions to this right of access, including when the information is used solely for scientific or statistical purposes.

You can see the research projects to which the Danish National Biobank has released biological material here: Framework for the release of biological material from the DNB for research purposes

Although there are limitations to the right of access, the researcher who receives samples for a research project may be obliged to inform the individuals from whom the samples originate that their samples will be included in a research project. You may therefore receive information from a researcher that samples from you will be used in a research project.  

When a research ethics committee approves a specific research project, the committee can also decide that the research project can be carried out without obtaining informed consent from you.

If you are registered in the Tissue Use Register, samples from you cannot be handed over for research.

If samples from you are used in a research project, the researcher is obliged to assess whether you should be informed in accordance with the data protection rules (GDPR). You may therefore receive information from a researcher that samples from you will be included in a research project.

The Danish National Biobank stores many different types of samples. Some samples, such as heel-prick blood samples from newborns, are relevant to keep for long-term use for the child and its family.

Other samples are stored for as long as they are necessary for SSI’s statutory tasks. SSI will often need to keep samples that are several decades old. This may be necessary so that SSI can look back in time and, for example, study how viruses and bacteria previously caused illness in humans compared to today. The oldest samples in the Danish National Biobank are from the 1970s.

When the samples are no longer necessary for SSI’s statutory tasks and no longer have statistical or scientific value, they will be destroyed. Thus there is no set time period for storing biological samples in the Danish National Biobank. Common to all samples, however, is that they are only stored as long as they are necessary for treatment purposes, for the prevention and control of infectious diseases, or if they have statistical or scientific value.  

Samples cannot be released to insurance companies, and insurance companies are not allowed to process information about individuals’ health risks.

Samples also cannot be used for forensic purposes with the aim of identifying criminals.

In a few cases, biological material has been used for the identification of victims, mainly in connection with accidents - for example, during the tsunami in Asia in 2004. In that situation it was not possible to identify potential Danish victims based solely on body parts. With a court order, the relevant PKU cards were retrieved, and a genetic analysis was able to confirm the identity of Danish victims.

The operation of the Danish National Biobank is financed by a government appropriation, and samples are only released for specific research projects that have been approved by a research ethics committee as well as by the Biobank’s advisory committee, and in some cases also by the Danish Data Protection Agency.

Access to samples is free of charge for researchers, unless the samples need to undergo specific processing before they are handed out.
Read more here:  Framework for the release of biological material from the DNB for research purposes