12. november 2018

Where to submit my notification?

Should I send my application to a regional committee or to the national committee? Find the answer here.

You must notify your research project to the regional committee in the area where you work as investigator.

If you are the investigator, you should therefore first and foremost contact the relevant regional research ethics committee. They will be able to answer questions about the research project at hand.

However, if the health research project involves especially complex areas, you must notify the project to the National Committee on Health Research Ethics (NCHRE). This is the case for the following type of research projects:

  • Health research projects involving children enrolled in clinical trials of medicines. These are to be notified via the Voluntary Harmonisation Procedure (VHP).
  • Health research projects involving advanced therapy medicinal products.
  • Health research projects involving extensive mapping of the human genome where exemption is applied for pursuant to section 10 of the Committee Act.
  • Health research projects involving psychosurgery.

Multi-centre trials must be notified to the regional committee in the area where the coordinating investigator works, unless the multi-centre trial involves the especially complex areas above.

Find contact information for the regional research ethics committees (in Danish only).