Projects without a health scientific purpose – Research Ethics Committee (REC) exemption statement

Research projects, including those without a health-scientific purpose, are increasingly subject to requirements from international journals, EU funding programmes, or collaborators to account for ethical considerations or provide documentation regarding ethical review. These requirements may go beyond what is required under Danish legislation.

In Denmark, statutory ethical approval is required only for certain categories of research, primarily within health science, health data science, clinical trials of medicinal products, and testing of medical devices. Many studies conducted at DTU therefore fall outside the Danish Research Ethics Committee system and do not require statutory ethical approval.

DTU is currently establishing DTU Research Ethics Committee (DTU REC) as a 1.5-year pilot initiative starting in summer 2026. DTU REC will provide advisory research ethics assessments and written statements for eligible studies involving human participants and/or human data that fall outside the Danish Research Ethics Committee system.

More information about DTU REC is available on these pages, and the DTU REC Inside pages will be expanded continuously during May and June 2026 with additional guidance and practical information.

DTU REC only assesses studies where data collection or participant involvement has not yet started. Researchers may therefore still need documentation that a study falls outside the Danish Research Ethics Committee system in situations where data collection has already taken place and external parties request such documentation.

For such cases, DTU currently offers a REC exemption statement through the process described below.

Conditions for issuing a REC exemption statement

• A REC exemption statement is only provided if it has been explicitly requested by a journal, funder, collaborator, or similar party.
• The statement confirms:
  • That DTU is a public university governed by general Danish regulations and principles.
  • That projects not falling under the Danish Ethics Committee system are not legally required to undergo REC assessment in Denmark.
  • That the specific research project is not notifiable to the Danish Ethics Committees.

It also includes the researcher’s name, DTU department, and project title.

Important: DTU will only issue a REC exemption statement if it can confidently confirm that the project is not notifiable to the Danish Ethics Committees. Researchers must be especially cautious of what research is considered notifiable to the Medical Research Ethics Committees (MREC) that handle applications for clinical trials with drugs (CTR) and tests of medical equipment.

The researcher is fully responsible for obtaining any necessary statutory ethical approvals. DTU will require the researcher to consult with the Danish Ethics Committees in case of doubt. This process is usually straightforward and quick. If the project is assessed not notifiable, the committees will issue a case number and official documentation—often such documentation is considered more effective to meet external requirements than the REC exemption statement issued by DTU.

How to request a REC exemption statement from DTU

1. Email the following to researchethics@adm.dtu.dk:
   • Project title
   • Timeline for data collection (planned or completed)
   • A brief project description or research protocol
   • The reason you are requesting a REC exemption statement (e.g., journal requirement)
     
     
2. The Research Office will review the submission and may follow up with additional questions to clarify whether the project is notifiable under the Danish Research Ethics Committee system.
   
   
3. If the project is clearly not notifiable, a draft REC exemption statement will be prepared and submitted for final approval and signature by DTU’s Provost.
   
   
4. If there is any uncertainty, the researcher will be referred to the Danish Research Ethics Committees for clarification.

Eligibility: Only researchers employed by DTU are eligible to request a REC exemption statement from DTU.

If you conduct research involving human participants for non-health scientific purposes, further guidelines can be read on the page 'Personal data - questionnaires, interviews and observations'