Research Ethics

Research conducted in Denmark is subject to different research ethics requirements depending on the type of research. Statutory research ethics approval is only required for specific categories of research defined by Danish legislation and applicable EU regulations. The pages below explain the Danish research ethics framework and help you identify the research ethics requirements relevant to your research.

Research involving human trial subjects and human biological material

If you conduct research with a health scientific purpose involving human trial subjects or human biological material, you need ethics approval from one or more of the Danish ethics committees.

Requirements for clinical trials and testing of medical devices and drugs

If your research project involves clinical trials of medicinal products, device trials, in vitro diagnostic devices, and testing of medical devices and drugs, you need ethics approval from MREC. A few exemptions apply.

Picture: DTU license - Photographer: Mikkel Adsbøl

Projects without a health scientific purpose – Institutional Review Board (IRB) exemption statement

If your research does not have a health scientific purpose, you do not need ethics approval from a Danish ethics committee. However, ethical considerations are still important and external requirements (e.g., from journals) may still apply, so obtaining an ethical assessment (IRB exemption letter) may be necessary.

Picture: DTU license - Photographer: Nicolai Perjesi

Personal data - questionnaires, interviews and observations

Regardless of whether your research has a health scientific purpose, you must comply with GDPR regulations and obtain informed consent from participants. This page provides the necessary information to help you meet requirements when you conduct interviews, questionnaires and observations.

Research involving animal experiments

All animal experiments carried out in Denmark require approval from the Animal Experiment Inspectorate. Read about the scope of the law, information about the application procedure, and how to optimize animal welfare – the 3R principles.

Picture: The official EU website, used under DTU's Visda license

Research ethics in Horizon Europe

Utilization of non-human genetic resources for research (Nagoya protocol)

Working with non-human biological material? Ensure that you are compliant with regulations on Access and Benefit Sharing (ABS). If you collect non-human biological material outside Denmark you should always ensure that you comply with ABS regulations, if any, or other relevant legislation in the provider country. Read more about the regulations on this page.