The research ethics committee system
To ensure that health research projects are conducted in an ethically responsible manner, a research ethics committee system has been set up, consisting of regional committees and The National Research Ethics Committee (DNVK).
The research ethics committee system has been established under the Danish Act on Research Ethics Review of Health Research Projects.
Any health research project should as a general rule be capable of being reported to the research ethics committee system, see Section 14 of the Act.
For the purposes of the Act, a health research project is defined as a project that includes trials involving liveborn human individuals, human gametes intended for fertilisation, fertilised human eggs, embryonic cells and embryos, tissue, cells and genetic material from humans, embryos, etc., or deceased persons. Also included are clinical trials of medicines in humans and clinical trials of medical devices, see Section 2, item 1, of the Act referring to the definitions in items 2 and 3 of the same provision.
Detailed guidelines on notification, mandatory reporting, etc. are available in Danish.
See also the research ethics committee’s website.