Overview of access rules in Denmark
To obtain biological samples an approval from a research ethics committee (there are five regional committees and one national committee which deals with larger projects) and the Data Inspection Agency is required. An application is then made to the biobank of interest, who then evaluates the project. In some cases a local collaborator is required to obtain samples. In the majority of case a Danish non-profit collaborator is required to obtain samples. In general private companies cannot gain access to Danish PIN numbers (CPR numbers) and thereby potentially identify individuals. Non-profit researchers can get access to PIN numbers, if they have a valid reason (such as linkage to e.g. clinical information or other register information).
The Danish National Biobank offers to act as liaison partner in projects where samples are not stored in the Danish National Biobank, but in other biobanks throughout Denmark. It is not a requirement, but an offer to researchers. More information regarding how to gain access can be found on danishnationalbiobank.com
A step-to-step guide to access Danish Biobanks
1. Identify biobank with the required sample collection.
– For more detailed information, visit the respective biobank website.
2. Apply for approval from a Danish Research Ethics Committee (REC).
– For small to medium projects, select one of Denmark’s five regional committees.
– For larger projects, apply to Denmark’s national committee.
3. Apply for approval from Danish Data Inspection Agency.
4. Submit an application for access to the selected biobank.
– Use the correct application form specified by the biobank.
– Include a thorough description of the project and all samples required.
– Send your application to the address specified by the biobank.
5. Application assessed.
6. Terms of delivery & service agreed, and contract signed.
– Will vary depending on biobank.
6. Samples / data retrieved & dispatched.
– In accordance with contractual terms.
Access to biological samples is mainly regulated by three Danish laws.
The local adaption to the EU General Data Protection Regulation (GDPR) is called the Data Protection Act. It regulates the handling and sharing of sensitive information. For research the Danish legislation is relatively liberal.
The Danish Health Act
According to the Danish Health Act a researcher can gain access to biological samples in biobanks with an ethical committee approval, and if the individual has not chosen to not participate with biological samples in research project. The individual can exert this right by signing up in the Vævsanvendelsesregister (use of tissue register).
The Committee Act.
Under the Committee Act, it is the responsibility of the committee system on health research ethics to ensure that health research projects are carried out in an ethically responsible manner, and that the rights, safety and wellbeing of trial subjects are protected, while at the same time possibilities are being created for the development of new, valuable knowledge.
The Registers and Biobanks in Transition” strategic initiative is funded by EIT Health