Guides to data access and approvals
On this page you will find overviews of the application processes with the various data providers and legal agencies before you can access data or obtain approvals for your research project.
Below are the various data providers and legal agencies listed.
Click on the one you want to read more about.
NOTE. These guides are for guidance only and should not be seen as a definitive answer.
If in doubt, please contact the relevant authorities.
Danmarks Nationale Biobank
1. Indhent godkendelse fra Videnskabsetisk Komité og fortegnelse
Projekter der omhandler menneskeligt biologisk materiale kræver godkendelse ved en Videnskabsetisk Komité, hvilket du kan læse mere om her: Hvad skal jeg anmelde? | Nationalt Center for Etik
Databeskyttelsesforordningen stiller krav om, at alle dataansvarlige og databehandlere fører interne fortegnelser over deres behandling af personoplysninger. Hvilket du kan læse mere om her: Vejledning om fortegnelse (datatilsynet.dk)
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2. Ansøgning gennem Forskerservice ved Sundhedsdatastyrelsen
Der skal ansøges gennem den fælles nationale indgang til biologi og data, som sker via Forskerservice ved Sundhedsdatastyrelsen, som findes her: Ansøg om biologisk materiale – Sundhedsdatastyrelsen
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3. Sagsbehandling foretages af Danmarks Nationale Biobank
Alle indkomne ansøgninger behandles af Biobankens Indstillingsudvalg (BIU).
BIU vurderer ansøgninger i den rækkefølge de modtages og tilstræber at svare forskeren inden for 1 måned efter modtagelse af komplet ansøgning.
Adgang til biologisk materiale (nationalbiobank.dk)
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4. Adgang til materiale
Der aftales vilkår for udlevering mellem DNB’s laboratorium og forskeren.
Prøverne fremfindes og udleveres.
Adgang til biologisk materiale (nationalbiobank.dk)
Danmarks Statistik
1. Være i et autoriseret forsknings-/analysemiljø
For at få adgang til data på Forskermaskinen skal du arbejde i eller samarbejde med et autoriseret forsknings- eller analysemiljø. At være autoriseret betyder, at der er foretaget en vurdering af et miljøs forskningsaktiviteter og kendskab til datasikkerhed og registerdata. Det er et miljø, der bliver autoriseret, og miljøets chef er ansvarlig for autorisationen.
Dette kan man læse mere om her: Autorisering af forskningsinstitutioner – Danmarks Statistik (dst.dk)
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2. Indsendelse af juridiske godkendelser/tilladelser (VEK, fortegnelse osv.) til projektet
Sundhedsvidenskabelige og sundhedsdatavidenskabelige forskningsprojekter kan have anmeldelsespligt til en videnskabsetisk komité. Der kan læse mere om hvad der skal anmeldes her: Hvad skal jeg anmelde? | Nationalt Center for Etik
Derudover, er man forpligtiget til at føre en fortegnelse over behandlingsaktiviteterne og dokumentere hvem der er dataansvarlig og databehandler. Dette kan man læse mere om her: Vejledning om fortegnelse (datatilsynet.dk)
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3. Afklaring af dataansvar og projektgodkendelser
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4. Godkendelse af projektindstillingen og forsker accepterer pris
Ansøgeren kommer med et udspil til hvilke variabler og tidsserie, der ønskes, hvorefter en detaljeret udtræksbeskrivelse udarbejdes. Når der enighed om dataudtræksbeskrivelsen, udregnes et endeligt pristilbud.
Introduktion til Forskningsservice i Danmarks Statistik (dst.dk)
Prisen på en opgave i Forskningsservice er baseret på den tid, det tager at løse opgavens delelementer. Danmarks Statistik (DST) har to typer af prisaftaler: fastprisaftaler og rammeaftaler.
Både fastprisaftaler og rammeaftaler er baseret på den tid, det tager at behandle og levere en opgave. Tiden afregnes efter den til enhver tid gældende timetakst.
Man kan læse mere om prisaftaler ved DST her: Priser – Danmarks Statistik (dst.dk)
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5. Brugeraftaler
Der udarbejdes en kontrakt på projektet og arbejdet med dataudtræk påbegyndes normalt efter modtagelse af underskrevet kontrakt.
Introduktion til Forskningsservice i Danmarks Statistik (dst.dk)
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6. Adgang til materiale
Adgang til data gives på forskermaskinen når Forskningsservice har oparbejdet de projektspecifikke data.
DATA PROVIDERS
BIO- AND GENOME BANK DENMARK (RBGB)
1. Contact RBGB for clarification of available material
When you wish to obtain data/samples from RBGB, it is recommended that you contact RBGB before the project is reported to the Scientific Ethics Committee and the regional research record. RBGB is a clinical biobank, the description of the data flow in the documents will therefore be different from a research biobank created without collaboration with RBGB. You can also request general figures about the inventory in RBGB (anonymized data), for example how many blood samples from patients with breast cancer are available in the biobank. These figures can form a good basis for the application.
RBGB_Vejledning-til-forskere_20210125_GODKENDT.pdf
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2. Obtain approval from a scientific ethics comittee, approved data notification and regional research record
Projects dealing with human biological material requires approval by a scientific ethics committee, which you can read more about here (in Danish): Hvad skal jeg anmelde? | Nationalt Center for Etik
In addition, you are obliged to keep a record of the processing activities and document who is the data controller and data processor. You can read more about this here (in Danish): Vejledning om fortegnelse (datatilsynet.dk)
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3. Create a research biobank to store samples (if required)
A research biobank can advantageously be set up when the biological material have to be stored beyond the time it takes to analyze the samples, which will typically be approximately 5-7 days.
Biobanker | Nationalt Center for Etik
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4. Approval by RBGB
Application for delivery of material and linked data as well as relevant documents (e.g. scientific ethics committees approval and approved data report etc.) are submitted to RBGB. A cooperation agreement is then prepared which is signed by both parties.
RBGB_Vejledning-til-forskere_20210125_GODKENDT.pdf
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5. Access to material
Based on the application form, the RBGB secretariat or the local center project manager makes a search for the material. RBGB is responsible for the overall coordination of the collection and delivery for the applying project. The relevant fractions will then be found and sent to the agreed delivery address.
RBGB_Vejledning-til-forskere_20210125_GODKENDT.pdf
The Danish National Archives
Dataset for free download
Free access to material
Typically applies to data that is older than 20 years and that does not contain personal data
or other sensitive or classified information.
Data containing personal data is only freely available after 75 years.
Researcher Service – Rigsarkivet en
Data that requires application and approval
1. Contact the Danish National Archives before applying in case of doubt
Contact the Danish National Archives before starting the application process, as some systems and data types require specific applications
to obtain approval. The Danish National Archives can help with clarification and applications
and thus optimize the possibility of being approved for data extraction.
The Danish National Archives can be contacted by email: data@sa.dk
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2. Initial case processing
Access is requested in the Danish National Archives database (in Danish): Søg efter digitalt skabte data (rigsarkivet.dk)
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3. The Danish National Archives obtains permits for the release of data
The Danish National Archives must obtain permission for release from the researcher or authority that produced the data before they can release it. In addition, the Danish National Archives obtains permission from the Danish Data Protection Authority if the data is younger than 75 years old and contains information about individuals’ purely private affairs.
NOTE: It must be pointed out that permits are personal and there will therefore only be those researchers etc. which is entered in the application, who can get permission to work with data.
Researcher Service – Rigsarkivet en
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4. Data is provided
Once you have received permission to use data with information about individuals’ private affairs,
you will receive the data on an encrypted USB stick.
Researcher Service – Rigsarkivet en
The Danish Clinical Quality Program – National Clinical Registries (RKKP)
1. Application for data access at RKKP
Researchers who need data in connection with research can, under certain conditions, gain access to data from the clinical quality databases. The application is made via the online application system on RKKP’s website (in Danish): RKKP-forskningsadgang
In English – RKKP
Health science and health data science research projects may have an obligation to report to a scientific ethics committee. You can read more about what must be reported here (in Danish): Hvad skal jeg anmelde? | Nationalt Center for Etik
You are obliged to keep a record of the processing activities and document who is the data controller and data processor. You can read more about this here (in Danish): Vejledning om fortegnelse (datatilsynet.dk)
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2. Case management and processing
The application is processed in RKKP, which ensures that formal conditions for disclosure are met. When formal conditions are met, RKKP registers the application as received.
(in Danish)
retningslinjer_forskning_version6_3.pdf (rkkp.dk)
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3. Case processing in the RKKP team of the relevant clinical database
The application is assessed based on:
• Consistency etc. completed list of variables and protocol/application in general.
• Whether the requested data is available – including whether the desired extract can be defined unambiguously.
The application is forwarded from here to the Steering Group for the relevant clinical database.
(in Danish)
retningslinjer_forskning_version6_3.pdf (rkkp.dk)
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4. Case processing in the steering committee for the relevant clinical database
The steering committee assesses whether the requested data is factual, necessary and relevant to complete the study and can enter into a dialogue with the applicant about any adjustment of the protocol.
(in Danish)
retningslinjer_forskning_version6_3.pdf (rkkp.dk)
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5. Data access
The Danish Health Data Authority
1. Apply for data
In order to gain access to register data for research from the Danish Health Data Agency, you have to clarify where
the processing of data is taking place. This determines which application form you have to use.
You can apply to have data transferred to The Secure Research Platform at the Health Data Agency or Statistics Denmark.
In special cases, data can be transferred for data processing elsewhere.
Next, you must submit an application to Research Service via the relevant electronic application form.
The application must contain a description of the project and the data applied for (project description and extract description),
a completed order sheet, where it is marked which variables you want access to, as well as relevant approvals and permits in relation to the project.
Apply for data – Sundhedsdatastyrelsen
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2. Be associated with an authorised research/analysis environment
As a starting point, the Danish Health Data Agency gives access to data on The Secure Research Platform.
To gain access to data via The Secure Research Platform at the Danish Health Data Agency, you must be associated with an authorised research or analysis environment.
Being authorised means that an assessment has been made of the environment’s research activities and knowledge of data security and register data. It is the environment that is authorised, and the head of the environment is responsible for the authorisation.
An authorisation allows users under the authorisation to access data on projects that are associated with the authorisation.
Before applying for data – Sundhedsdatastyrelsen
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3. Clarification of data responsibility and approvals
The first step in the case processing process is clarification of whether you have the right to have data transferred.
Your project must be approved by your institution responsible for the data and therefore included in the institution’s record of the processing activities. If your project also requires permission from other agencies, e.g. the Scientific Ethics Committee, you also have to send these documents together with the application.
Health science and health data science research projects may require approval by a scientific ethics committee, which you can read more about here (in Danish): Hvad skal jeg anmelde? | Nationalt Center for Etik
In addition, you are obliged to keep a record of the processing activities and document who is the data controller and data processor. You can read more about this here (in Danish): Vejledning om fortegnelse (datatilsynet.dk)
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4. Agreement on data access
Once we have established that you have the right to process data, we will devise an agreement on data access in collaboration with you, which specifies the data you will get access to. You can get access to the data that is necessary and sufficient to complete your project.
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5. Access to data and invoicing
Once the data access agreement has been completed, access to data can be granted.
If you have applied for access to data on the Danish Health Data Agency’s Secure Research Platform, you must enter into an user agreement in order to be able to access the data. (In Danish) Sundhedsdatastyrelsens skabelon om anmodning af brugeradgang
Research Service charges for processing applications and providing access to data. The price depends on the time spent on the application and is settled at a fixed hourly rate. (In Danish) SDS notat (sundhedsdatastyrelsen.dk)
LEGAL AGENCIES
The Regional Research Ethics Committee
Health science research projects that do not relate to particularly complex areas
As a starting point, you must report health science research projects with humans, as well as
experiments with tissues, cells, etc. to the regional committee for the area where you work as principal investigator.
However, experiments with pharmaceuticals, medical equipment or in-vitro diagnostic equipment must be reported to the Scientific Ethics Medical Committees.
Hvortil skal jeg anmelde? | Nationalt Center for Etik
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1. Send an inquiry regarding the obligation to notify in case of doubt
If there is doubt as to whether one’s project requires scientific ethics approval, contact the Regional Scientific Ethics Committee for the region in which the researcher operates, to get an assessment of the reporting obligation.
Hvad skal jeg anmelde? | Nationalt Center for Etik
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2. Notification of the project (notification form and project material)
Applications must be made electronically by filling in a notification form in the committee system’s electronic notification database (in Danish): http://www.drvk.dk/anmeldelse
Once the electronic form is completed and submitted, it must be printed.
Both the notification form and project material must be sent to the competent scientific ethics committee using secure mail and a digital signature. The material must be sent in separate files as a PDF or ZIP file.
An overview of which documents that must be submitted can be found here (in Danish): Hvilke dokumenter skal jeg indsende til NVK og RVK? | Nationalt Center for Etik
Read more on the National Center for Ethics website (in Danish): Sådan anmelder du elektronisk via anmeldelsesdatabasen til NVK og RVK | Nationalt Center for Etik
The National Research Ethics Committee
Research projects concerning particularly complex areas
Health data science and health science research projects that fall within one of these categories must be reported to the National Research Ethics Committee:
• Comprehensive mapping of the individual’s inheritance, in which a dispensation from the
consent requirement pursuant to Section 10 of the Committees Act is applied for.
• Health data research projects without biological material with already
existing genome data or already existing image diagnostic data.
• Psychosurgery.
• Research on a deceased person as part of extracting their organ.
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1. Send an inquiry regarding the obligation to notify in case of doubt
If there is doubt as to whether one’s project requires scientific ethics approval, contact the National Research Ethics Committee, to get an assessment of the reporting obligation.
Hvad skal jeg anmelde? | Nationalt Center for Etik
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2. Notification of the project (notification form and project material)
Applications must be made electronically by filling in a notification form in the committee system’s electronic notification database (in Danish): http://www.drvk.dk/anmeldelse
Once the electronic form is completed and submitted, it must be printed.
Both the notification form and project material must be sent to the competent scientific ethics committee using secure mail and a digital signature. The material must be sent in separate files as a PDF or ZIP file.
An overview of which documents that must be submitted can be found here (in Danish): Hvilke dokumenter skal jeg indsende til NVK og RVK? | Nationalt Center for Etik
Read more on the National Center for Ethics website (in Danish): Sådan anmelder du elektronisk via anmeldelsesdatabasen til NVK og RVK | Nationalt Center for Etik
The Scientific Ethics Medical Committees
Research projects regarding pharmaceuticals, medical devices and in vitro-diagnostic equipment
Health scientific research projects that fall within one of these categories must be notified to the Scientific Ethics Medical Committees:
• Clinical trials with medicines
• Clinical trials of medical equipment
• Clinical trials of in vitro-diagnostic equipment
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Clinical trials with medicines
Report via Clinical Trials Information System (CTIS)
Applications must be submitted through CTIS (Clinical Trial Information System), which is a common EU portal and databases for clinical trials. All communication between the authorities and the applicant takes place through CTIS. The European Medicines Agency has created a training program for CTIS, which is recommended.
Anmeld nye forsøg under CTR | Nationalt Center for Etik
Clinical trials of medical equipment
Application to the Scientific Ethics Medical Committees and the Danish Medicines Agency (if necessary)
Applications must be submitted via application forms, which are sent directly to the Scientific Ethics Medical Committees. Tests of medical equipment require approval from the scientific ethics committee, which must be obtained before the test can be started. Depending on the type of trial, the trial may also have to be reported to the Danish Medicines Agency.
Read more about the application process and find the application forms here (in Danish): Anmeld kliniske afprøvninger med medicinsk udstyr under MDR | Nationalt Center for Etik
Clinical trials of in vitro-diagnostic equipment
Application to the Scientific Ethics Medical Committees and the Danish Medicines Agency (if necessary)
Applications must be submitted via application forms, which are sent directly to the Scientific Ethics Medical Committees. Depending on the type of clinical trial, it may have to be reported to both the Scientific Ethical Medical Committees and the Danish Medicines Agency. From the 26th of May 2022, there has been a change in the legislation, which means equipment for in-vitro diagnostics cannot be put into use until it is CE-approved and must therefore go through a test. The test must not be started before it has been approved by the Scientific Ethics Medical Committees.
Read more about the application process and find the application forms here (in Danish): Kliniske afprøvninger med medicinsk udstyr til in vitro-diagnostik under IVDR | Nationalt Center for Etik
Regional research record
1. Report to the data controller organisation(s)
A regional research record is an overview of processing activities and contains information about who processes sensitive personal data and for what purpose. All projects that process or store personally identifiable data must be notified.
This means that if you have personally identifiable data in a project, you are obliged to keep a record of the processing activities and document who is the data controller and data processor.
Notification of the research record must typically be made to the institution where the project manager is employed. If the research originates from a hospital, it will typically be the region, but could just as well be a university or a company.
Read more about the research record here (in Danish): Vejledning om fortegnelse (datatilsynet.dk)
Patient record data (the Regional Council)
Approval from the Regional Council or the Scientific Ethics Committee
To gain access to patient record information, an approval for the transmission of medical record information is required.
This approval can either be obtained through theRegional Council or the Scientific Ethics Committee,
depending on the requirements of your project.
Projects that require scientific ethics approval must apply for approval for the transmission of patient record information in the general application to the Scientific Ethics Committee. Read more about what must be reported to the Scientific Ethics Committee here (in Danish): Hvad skal jeg anmelde? | Nationalt Center for Etik
Projects that do not require scientific ethics approval must apply for the transmission of patient record information
to the Regional Council in the region where the researcher is employed.
(Quality assurance or quality development projects must seek approval internally from the management of the treatment facility.
Read more about this in the Quality Assurance or Quality Development Projects section of this page)
1. The application form is sent directly to the relevant agencies/regional council
To gain access to patient records through the regional councils, an application form must be completed, which can be found on the various regions’ websites. The application form must be sent by mail to the relevant agency/regional council, in the region where the researcher is employed, which is responsible for the approvals for the transmission of patient record information.
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2. Authorization for transmission
According to the Health Act, the case processing time must be a maximum of 35 calendar days. The deadline runs from the time a duly completed application that meets the formal requirements for information and potential documents has been sent. It is therefore important that all fields in the application are filled out thoroughly, as incomplete or defective applications lead to an extended processing time.
Videregivelse af patientjournaloplysninger til forskning, statistik og planlægning
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3. Agreement on transfer of patient record information
A permission to pass on information does not imply that you can freely obtain the information yourself in e.g. electronic patient record (EPJ). If you have been granted permission for transmission pursuant to Section 46, subsection 2, you can, however, obtain permission for your own retrieval in the patient record from the management at the treatment facility, cf. § 46, subsection 5.
Videregivelse af patientjournaloplysninger til forskning, statistik og planlægning
This means that you yourself must contact the agency or department through which you wish to receive patient record information. They can then collect and hand over the information to you or you can be allowed to collect the information yourself if you have been given permission to do so.
Quality assurance or quality development projects
Report to the local management
Quality development projects must seek approval internally from the management of the treatment facility.
The distinction between quality and research projects can be difficult. The Danish Agency for Patient Safety has defined research as a planned work which aims to systematically acquire knowledge about the onset of disease and about its prevention, diagnostics and treatment. The work must be planned, and the purpose must be a systematic acquisition of knowledge. Thereby, research is separated from quality projects and quality control, where it is an activity that forms part of the health service’s operation, for example a hospital department’s achieved treatment results for a given patient group. If there are any doubts whether it is a quality or research project, it is recommended to contact the local hospital management for clarification.
Patientjournaloplysninger til forskning, statistik eller planlægning (regionsyddanmark.dk)
The North Denmark Region has a diagram that can be used to assess whether one’s project is a quality or a research project (in Danish): Er mit projekt et kvalitets- eller et forskningsprojekt? (rn.dk)
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Quality assurance or quality development projects that wish to use patient record data
Acquisition of patient record data for use in quality assurance or quality development projects must only be approved by the management at the treatment facility, cf. section 42 d, subsection of the Health Act. 2.
Patientjournaloplysninger til forskning, statistik eller planlægning (regionsyddanmark.dk)
The content on the page is produced by Marie Sandstød and Kasper Westphal Leth.
Last updated: 22/12/2023
