Single point of access to research health data
Where do I apply for access to data, medical records and biological samples? And where and how do I apply for permission to perform human subject research? Find the answers here.
If your research project requires health data from different sources, you need to apply for access to data from different authorities. Often, a permit from one authority will be a prerequisite for accessing data from another. Below we present some questions that can help you determine which authorities to send your application to and in which order.
You can also find links to the following authorities:
- The Danish Health Data Authority’s Research Support
- Health Research Ethics Committees
- Danish National Biobank
- Danish National Genome Center
- The Danish Clinical Quality Program – National Clinical Registries
- Bio- and Genome Bank Denmark
- Use of medical records for research purposes
Are you going to do human subject research or human biological material research?
Research projects involving human subject research (living or deceased) or human biological material from, for example, the Danish National Biobank or Bio- and Genome Bank Denmark, constitute health sciences research projects, which must be notified to the competent health research ethics committee. Read more
Do you need biological samples?
Then you must send your application to one of the Danish biobanks. For example, the Danish National Biobank or Bio- and Genome Bank Denmark. Before accessing biological samples, you must obtain permission from one of the health research ethics committees, so you should apply here first. Read more
Do you need genetic information?
If your research project requires data from the Danish National Genome Center’s genome database, you must apply for access to relevant pseudonymised genetic information. Please note that it is not possible to extract data from the Danish National Genome Center. But you are welcome to download analysis results instead. Read more
Do you need to access medical records?
Medical records contain data collected for use directly in the patient’s treatment. Medical records comprise different types of data, for example, data from the national Pathology Data Bank (Patobanken), data from laboratory information management systems and data from patient management systems. You need a separate permit if your project requires access to information from medical records.
If you conduct human subject research, biological material research or use sensitive bioinformatics data, your approval from the health research ethics committee could comprise permission to receive subjects’ medical records. In addition, the research subject must consent to being part of the trial in order for you to access medical records information (including electronic information) about the subject.
If you use imaging data from medical records as your primary registry research (for example, X-ray or MRI), you should be aware that it must be reported to the competent health research ethics committee as a health data science research project. Read more
Do you need data from the national health registries?
If your project requires individual data from the national health registries, you must apply for access to data from the Danish Health Data Authority’s Research Services or Statistics Denmark. Data from the national health registries may be the only data source of a research project or they may be included in a research project together with other data sources. If other data sources, such as human biological material or medical records, are a key element of the project, the permits to use these data must be in place before your application for registry data is processed. Read more
Do you need data from the clinical quality databases?
Data in the clinical quality databases contain information about patients’ diseases and treatment in the healthcare system. These data are used to analyse and improve the quality of patient care in the Danish healthcare system. Read more
In future, there will only be one single point of data access
It can be difficult to determine which authorities to send your applications to and in which order.
The ambition of the new application portal is to provide a single point of data access for health researchers: the new application portal. From the portal you will be able to send your application to several authorities at the same time. The plan is to integrate online application system with the Guidance page to support the entire application process. Until this function is available, you can find links to the different authorities on this page.
Research Services promotes health research in Denmark by providing access to and advising on the use of national registry data in the field of health.
Research Services provides access to data via the secure research platform “Forskermaskinen”, which provides online remote access to data from the national health registries in a secure environment. On Forskermaskinen, data are pseudonymised, but you can still link data from the health registries with your own data, which you can upload to Forskermaskinen. Please note that Statistics Denmark can also provide health data for research projects.
If you have a particularly justified need, you can apply for the necessary data to be transferred to a data processor other than Forskermaskinen. Such data could be civil registration numbers to identify information in medical records, biobanks or to collect information from registries outside the Danish Health Data Authority. Read more about the rules on data access applications here (in Danish).
How to apply for data access
If you need data, you must apply for access via the electronic application form on our website. The website also contains information about the registries.
In addition to a project description and the data extraction requested, you must also enclose your application, your data processing agreement with your data controller and other relevant approvals as mentioned above. Read more here (in Danish).
What is the average application processing time?
Research Services aims to process your data access application within 30 working days on average. However, please see the current processing time in our newsletter on our website.
The Health Research Ethics Committees process applications for approval of health science and health data science research projects.
The purpose of the committee system is to ensure that health science and health data science research projects are carried out in a science-ethically sound manner. The subjects’ rights, safety and well-being take precedence over scientific and societal interests in, for example, obtaining or developing existing knowledge. You can read more about the committee system here.
Which research projects must be registered with the health research ethics committees?
If you are conducting health science or health data science research, you must always apply to a health research ethics committee for approval.
This applies, for example, if you:
- Conduct clinical trials involving living trial subjects, including drug trials
- Use biological material from biobanks or deceased (for example, from autopsies) in your research
- Research sensitive bioinformatics data with a risk of significant secondary findings. This applies to research involving genome data or imaging data created in previous research projects or in connection with clinical diagnostics of patients
Read more about the types of research projects which require approval from the health research ethics committees here.
How to apply for approval of your research project
You can apply for approval electronically by completing a notification form in the electronic notification system. Instructions on how to complete the electronic form are available in the system.
Once you have completed and submitted the electronic form, remember to print it. The notification form and project material must be sent to the competent health research ethics committee using secure email and digital signature. The material must be sent in separate files in PDF format or in a ZIP file.
Please note that the health research ethics committee system consists of the regional health research ethics committees and the National Committee on Health Research Ethics. See here which committee you must send your application to.
Find an overview of which documents you need to submit along with the requirements for project material content here:
The Danish National Genome Center (NGC) is an agency under the Danish Ministry of Health. The NGC provides a secure technological infrastructure for the use of genetic information for treatment of patients and individualised medicine research.
This infrastructure consists of the genome database and a research infrastructure.
The genome database
The genome database is a newly developed security system for storing genetic information obtained from treatment of patients and research from across Denmark.
If you want to use data from the genome database for your research project, you must apply for access to relevant genetic data in pseudonymised form. Please note that you cannot extract data from the genome database. However, you are free to download analysis results.
The research infrastructure
The research infrastructure is an advanced and extremely secure cloud solution with extensive storage and computing capacity. It is capable of linking extremely large amounts of heterogeneous data from various external sources and of handling new data. This means, for example, that data stored by external authorities can be linked with both own data and data from the genome database.
Researchers can apply for access to a ‘private secure c
loud’ in the research infrastructure. The NGC customises the specific ‘private secure cloud’ to the individual researcher and the individual project to accommodate individual needs. Whether the researcher uses own data or data from other external authorities may, for example, change the requirements.
Please note that the data responsibility lies with the project manager and that the general rules for register research apply.
The NGC will open for access to the research infrastructure and the genome database in 2021.
Read more about the application process and prices at the NGC.
The Danish Clinical Quality Program (RKKP) is an interregional network constructed around the clinical quality databases, clinically anchored steering committees and the RKKP knowledge centre.
The clinical quality databases contain information on patients’ diseases and course of treatment in the Danish healthcare system and are used to analyse and improve the patient treatment quality.
How to apply for data access
You are encouraged to use data from the clinical quality databases in your research. However, please remember that you must meet our application requirements, which you can read more about here (link See guidelines for access).
Do you have questions on how to apply for data access? The RKKP knowledge centre assists with application and data disclosure and establishes contact between the database steering committees and applicants.
The Danish National Biobank is one of the world’s largest and most advanced biobanks, making it a unique resource for research into the causes, prevention and treatment of diseases.
The biobank contains more than 12 million biological samples, which are handled by a total of 15 robots. The samples cover virtually all diseases and are of many different types. The Coordinating Centre guides and helps researchers gain access to samples and data.
With the help of the National Biobank Register, researchers can get a unique overview of more than 25 million biological samples available in Danish biobanks. The biological sample material from one individual can then be linked to the large amount of data available in the Danish national registries, for example health data.
The Danish National Biobank offers the opportunity to tap into the potential knowledge available in the vast amount of biological samples collected in the Danish healthcare sector. Some of the samples are stored in the Danish National Biobank while others are stored in other biobanks around the country.
Bio- and Genome Bank Denmark (RBGB) is a nationwide interregional infrastructure for biobanks. RBGB primarily comprises clinical biobanks, but also covers biobanks for other health purposes.
The health directors are the executive body of the structure, which consists of a steering committee for the RBGB, a nationwide secretariat with two functions: management of RBGB and management of the Pathology and Genetic Databank. Each biobank in RBGB is supported by a scientific advisory board. Information on biological material (metadata) is collected from all over Denmark.
RBGB contributes to:
- Implementing a national bio and genome bank
- Securing biological material for diagnostics and treatment of individual patients
- Facilitating research in Denmark as a cornerstone in Danish healthcare research
- Supporting the development of individualised medicine that can help tailor and optimise the patient care
- Ensuring easy and transparent procedures and facilitate access to biological material
- Being moderator of high-quality biological material
RBGB holds biological material comprising more than 221,000 blood samples, 96,000 tissue samples and 9,800 bone marrow samples. Each sample is divided into smaller fractions. All samples are provided with metadata, for example, date of sampling, type of material, diagnostic codes, physical location, patient consent and much more information.
Clinicians may contact RBGB and obtain information on high-quality material available for clinical use, e.g., diagnostics and treatment. Researchers can use RBGB to obtain a unique overview of suitable high-quality material potential being available for a research project.
RBGB helps prepare a correct description of workflows and data flow in connection with collection and use of materials.
Information on application and materials can be found on RBGB’s website. RBGB is happy to answer any questions you may have.
Please contact RBGB on +45 3868 9132/+45 3868 9812 or by email: RBGB.email@example.com
As of 1 July 2020, the authority to approve applications for disclosure of medical records for research purposes no longer lies with the Danish Patient Safety Authority. It now lies with the regional councils. The regional councils have subsequently delegated the task to the administration of the individual region.
This means that you must now contact the administration of the region where you want to apply for disclosure and use of medical records. This applies regardless of whether you apply for medical records from the region in which you are employed or from another region/municipality.
Below, please find links to the relevant administrations in the individual regions that process applications for disclosure of medical records:
If you wish to expand or change the criteria of a previously approved project, for example, timeframe, number of patients, request for further information etc., you must submit a supplementary application to the region that processed your application as specified above.