According to the Act on Research Ethics Review of Health Research Projects, any health research project must be notified to the system of research ethics committees (cf. Section 14 2-5).
Health research projects are defined as “projects that include trials involving live born human individuals, human gametes intended for fertilization, fertilized 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” (cf. Section 2-1).
Projects which only include administrative data should not be notified to a research ethics committee. (See Requirements to acquire approval from data protection authorities).
The National Committee on Health Research Ethics
Act on Research Ethics Review of Health Research Projects
Act on Research Ethics Review of Health Research Projects, 2011. DNVK [online] Available at: <http://dnvk.dk/English/actonabiomedicalresearch.aspx>. [Accessed 25. February 2014].
The National Committee on Health Research Ethics [online]. Available at: <http://www.dnvk.dk/CVK/Home/English.aspx>. [Accessed 25. February 2014].