Research Ethics

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

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.

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.

The four ethical principles and the Danish ethical committee system

Research ethics is based on the following four ethical principles: Autonomy, Beneficence, Non-maleficence, and Justice. National and international ethics regulations reflect those four principles, especially within health science. Read more about the four principles.

If your research project has a health scientific purpose, it falls within the Danish ethical committee system, and you must ensure ethical approvals before initiating any project activities. In other cases, if your project does not have a health scientific purpose, you may need an institutional review board (IRB) exemption letter from DTU documenting that your research activities are ethical.

All research projects, regardless of whether they have a health scientific purpose, must conform to national requirements for management, data handling, and research.

Make sure to pay attention to external requirements early in your project, especially those from the scientific journals where you plan to publish your research. Some journals require researchers to provide documentation of ethical clearance for their research activities. In some cases, a journal’s requirements may exceed national legislation, and non-compliance will almost certainly result in the rejection of your manuscript.

On the website of the Danish National Center for Ethics (in Danish), you can find further information on where, when, and how you apply for ethics approvals in the Danish ethics committee system. The website provides a comprehensive overview of mandatory reporting requirements and defines which committee oversees each specific research area.