Case #17: Which Scientific Ethics Committee must be reported to?
Cases are examples of questions and inquiries we receive in the Guidance Function, which we would like to share for inspiration.
A researcher contacted the Guidance Function with an inquiry regarding which scientific ethics committee the research project should be reported to.
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, reports must be made to one of the three committees mentioned.
- By default, health science research projects with humans, as well as experiments with tissues, cells, etc., must be notified to the regional committee for the regional area where the principal investigator works. (However, not drug trials or medical devices, as these have to be reported to VMK). If the trial is multicenter, you have to notify the regional committee for the area where the coordinating trial officer works
- Notification must be made to NVK if the research project involves extensive mapping of the individual’s genetic material, in which an exemption from the consent requirement pursuant to §10 of the Committees Act is applied for. For health informatics research projects with already existing genome data or already existing imaging data. In the case of psychosurgery or research on a deceased person as part of removal of their organ.
- VMK must be notified if the research project includes clinical trials with medicinal products, clinical trials of medical equipment, or clinical trials of in-vitro diagnostic equipment.
For further information, visit the website for the National Center for ethics (in Danish): Hvortil skal jeg anmelde? | Nationalt Center for Etik
In this case, we assisted the researcher to clarify which scientific ethics committee the research project should be reported to. We also included the information to the relevant scientific ethics committee in the region of the researcher.
Please feel free to contact us if you need guidance in your research project. Our services are free, and we aim to reply to any inquiries within 2-4 working days.
The Guidance Function offers first-level support for Danish and international researchers in need of help to navigate the requirements and processes surrounding research projects.
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