Below, you will find details on which type of ethics committee may be relevant if you conduct research involving human trial subjects and human biological material and your research project has a health scientific purpose.
While an ethics approval may not always be necessary, confirming this is crucial because, as a researcher, you must have the necessary documentation. If you are uncertain, the committees can help assess whether approval is required.
For all research projects involving human trial subjects and human biological material, you must ensure appropriate informed consent from participants and provide sufficient participant information. Read more about informed consent and participant information.
Regional Ethics Committee (REC)
If your research involves humans, human cells, tissue, and human data—used for health scientific purposes—and human intervention, you must apply for ethics approval at REC.
Multicenter trials must be reported to the regional committee for the area where the coordinating investigator is based unless the multicenter trial pertains to particularly complex subject areas.
For an overview of reporting obligations click the section ‘Who needs to approve the application’ (in Danish) at the National Ethics Committees website.
Your application must be sent via the application database.
Note: If your health research project concerns in-vitro diagnostic equipment, ethics approval from the Ethics Medical Committee (MREC) is required. Read more about the MREC.
Import of human biological material
When importing human biological material, for example, from a foreign clinical biobank, you must seek approval from REC. Additionally, the Principal Investigator must ensure and be able to document that the material has been collected ethically and in compliance with the legislation at the collection site.
An exception applies if you analyze material on behalf of a researcher abroad; in this case, you are not the Principal Investigator, and the research is not conducted in Denmark.
When importing and exporting material, including personal data, obtaining authorization from the EU for personal data transfer, including human biological material, is mandatory. The DTU GDPR Inside pages include an overview of relevant templates for this purpose. Please contact DTU’s GDPR team for further information regarding the record and transfer of personal data inside and outside the EU.
Additionally, securing a Material Transfer Agreement (MTA) is essential. Please contact your contract manager at the department. They will assist you. Contact Legal & Tech Transfer if further help is needed
Please consult the Danish National Center for Ethics (in Danish) for guidance if you are uncertain.
Regardless of the scenario, you must ensure documentation proving the ethically acceptable retrieval of the material, including ethics approvals.
If your research project falls within the research area covered by REC, you must always notify one of the 8 regional ethics committees about the project in question by email. Notifications must always include:
- Short project description
- Purpose
- Method - incl. information regarding trial subjects/biological material
Upon receiving the above information, a committee might issue an initial statement as to whether the project requires ethical approval under Danish law.
Use of truly anonymous biological material
An ethics approval is not required when utilizing biological material that is genuinely anonymous, meaning it is impossible to trace back to its source, either directly or indirectly (e.g., through deduction). It is important to note that biological material retrieved by the researcher is not considered anonymous.
Guidelines for determining when an approval is necessary for research involving biological material, including stem cell lines, fertilized eggs, and embryos can be found in Vejledning om brug af biologisk materiale i sundhedsvidenskabelige forskningsprojekter | National Videnskabsetisk Komité (nvk.dk)(in Danish).
National Ethics Committee (NEC)
You may need an ethics approval from NEC if you are conducting health-data research projects, i.e., not involving persons or biological material, and for projects where sensitive (special) bio-informatic data is involved and where there may be a risk of secondary findings of a significant nature. This includes areas such as genetic mapping, psycho-surgery, genome data, or imaging-diagnostic data generated from previous research projects or clinical diagnoses of patients.
You can find examples of investigations involving image-diagnostic data (in Danish) to help determine whether your research involves imaging-diagnostic data.
Your application must be sent via the application database.
Note: In certain instances, obtaining ethics approval from the NEC is necessary when using AI in your research. For example, if AI is used to analyze images of individuals or patients (such as x-rays or scans) to generate new insights, that could lead to innovative diagnostic methods or technologies, i.e., a health science purpose. Read more about the EU Commission’s definition of AI and EU’s guidelines for trustworthy AI.
No ethics approval for questionnaires, register-based research, and projects involving fully anonymized biological material
Research projects involving human trial subjects, such as questionnaires or interviews, are considered interventions. However, they do not require approval from an ethics committee unless they involve human biological material or otherwise meet the criteria specified by REC.
Similarly, register-based research and work with fully anonymized biological material or cell lines collected under an already approved project do not require ethics committee approval. It is important to note that achieving complete anonymization of Danish biological material is rarely feasible.
For other ethical considerations when conducting questionnaires, please see the Inside page Personal data- questionnaires, interviews and observations.