Eurecnet - National Information: Denmark

National Information: Denmark (Last Update: January 2023)

Short description of RECs system:

There are 12 regional committees. The National committee (the Danish National Committee on Biomedical Research Ethics (National Videnskabsetisk Komité, (NVK) ): coordinates the work in the regional committees, lays down guidelines for amongst others researchers, gives opinions on issues of a fundamental nature, if this is not related to the approval of a concrete research project, acts as an appeals committee in connection with findings in the regional committees and decide on matters where members of the regional committees disagree, monitors the development of research within the health sector and further the understanding of the ethical problems resulting from the development in relation to the health services and the biomedical research environments.

The National Committee consists of 13 members. 3 members, including the chairman, are appointed by the Minister of Health, 5 members are appointed by the Minister of Health together with the Minister for Science, Innovation and Higher Education, 5 members are appointed by the Minister of Health after recommendation of the regions The Danish National Committee on Biomedical Research Ethics coordinates the work of the regional committees. The Danish National Committee on Biomedical Research Ethics: Forside | Nationalt Center for Etik

Furthermore 3 Medical Research Ethics Committees are established. These committees work with the Clinical Trials Regulation, the Medical Device Regulation and the In vitro diagnostics Regulation. The committees are not regional but governmental. The Minister of Health appoints the chairman. 5 members are appointed by the Minister of Health after recommendation of the regions. 2 members are appointed by the Minister of Health after recommendation of patient organizations.

Networking between RECs:

A coordination forum with representatives from the secretariats in the National Committee, the Medical Research Ethics Committees and the regional committees is established. There is an annual meeting for all members of the ethics committee system and the staff.There is a current contact on emails and telephone between the secretariat for the national committee and Medical Ethics Committees with the secretariats of RECs with the purpose to coordinate and interpret the laws etc. At the same time there is current contacts between the staff of the RECs. Every four years – when new members of the committees are nominated – the national committee arranges a course of education.

Contact: eurec@eurecnet.org