Health research projects

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 is established by the  Danish Act on Research Ethics Review of Health Research Projects.

Any health research project should as a rule be 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, no.1 of the Act referring to the definitions in no. 2 and no. 3 of the same provision.

Detailed guidelines on notification, mandatory reporting, etc. are available in Danish.

See also the research ethics committee’s website.

See also the guidelines by the Ministry of the Interior and Health on how to get started with clinical research ”Kom godt i gang med klinisk forskning”.