Which Scientific Ethics Committee must be reported to?
The Guidance Function often receives inquiries regarding which Scientific Ethics Committee a research project should be submitted to. Therefore, we have created an overview of what needs to be submitted to each committee.
All health science and health data science research projects must be reported to a scientific ethics committee. (However, with the exception of some specified research projects, cf. the Danish Committee Act §14 subsections 2-5.) There are three different scientific ethics committees in Denmark to which research projects can be reported.
- The Regional Scientific Ethics Committees (RVK)
- The National Scientific Ethics Committee (NVK)
- The Scientific Ethics Medical Committees (VMK)
Depending on the type of research to be conducted, reporting needs to be made to one of the three mentioned committees:
- Regional Scientific Ethics Committees (RVK)
In principle, health science research projects involving humans and experiments involving tissues, cells, etc., should be reported to the regional committee covering the area where the principal investigator works (excluding drug trials or medical devices, as these fall under VMK). In multicenter trials, reporting should be made to the regional committee where the coordinating principal investigator works.
- National Scientific Ethics Committee (NVK)
Reporting should be made to NVK for research projects involving particularly complex areas:
- Extensive mapping of an individual’s genetic makeup with a request for dispensation according to § 10 of the Committee Act
- Research on a deceased person as part of organ removal
- Health data science research projects without biological material but with already existing genomic data or existing image diagnostic data
- Scientific Ethics Medical Committees (VMK)
Reporting should be made to VMK for research projects involving:
- Clinical trials with medicine (Reported through the Clinical Trials Information System (CTIS))
- Clinical testing of medical equipment
- Clinical testing of in vitro diagnostic equipment
You can find more information about what needs to be reported and where to report on the National Centre for Ethics’ website (in Danish).
Hvad skal jeg anmelde? | Nationalt Center for Etik
Hvortil skal jeg anmelde? | Nationalt Center for Etik
On the Guidance Function’s website, you can find guides to data access and approvals, where you can read more about how to apply to the Scientific Ethics Committees and find links to the individual Regional Scientific Ethics Committees.
Remember that the Guidance Function is a free advisory service for both public and private researchers, both Danish and international. You can always reach out to us at firstname.lastname@example.org or call us at +45 2494 7969.
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