How does the ethical review process work in Denmark and which are the designated ethics committees?
According to Danish law, all research projects in Denmark involving human beings or any kind of human tissue, cells etc. need permission from an regional ethics committee. In the case of medicinal and medicinal devices trial projects a permission from the Danish Medicines Agency is also required before the project can be initiated.
The investigator and the sponsor of the research project must apply for permission from the regional research ethics committee for the area in which the investigator is operating. The application should conform with the “Guidelines about notification etc. of a biomedical research project to the committee system on biomedical research ethics”.
The investigator and sponsor shall use an electronic application form: www.drvk.dk/anmeldelse and send the application on email to the competent research ethics committee along with the trial protocol and other information required for the committee’s assessment. The email must be send using a digital signature. Further information at the regional research ethical committees.
In the case of multi-center trials, the investigator shall only apply for permission from one regional committee, i.e. the regional committee in the area, where the principal investigator carries out the research project. However, in the case of multi-national trial projects, a permission from a Danish committee is always required.
The review of the application by the regional research ethics committee will take place when a complete and valid application has been submitted. A valid application must include the following elements:
- Application form
- The clinical trial protocol
- Subject information and the informed consent procedure
- A protocol resumé.
The trial protocol and other information can be received in english with a Danish protocol resumé. Further information at guidelines about notification. Applicants whose project is rejected by the regional ethics committee can appeal the decision at The Danish National Committee on Health Research Ethics.
Weblinks to Danish Ethics Committees