DENMARK

Legislation

• Act on Research Ethics Review of Health Research Projects (LBK nr 1338 af 01/09/2020)

• Clinical trials with medicinal products: REGULATION (EU) No 536/2014 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 16 April 2014 on clinical trials on medicinal products for human use, and repealing Directive 2001/20/EC

• The Danish Law on clinical trials with medicinal products: Bekendtgørelse af lov om kliniske forsøg med lægemidler, LBK nr. 1252 af 31/10/2018

• Clinical investigations with medical device: REGULATION (EU) 2017/745 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 5 April 2017 on medical devices, amending Directive 2001/83/EC, Regulation (EC) No 178/2002 and Regulation (EC) No 1223/2009 and repealing Council Directives 90/385/EEC and 93/42/EEC

• The Danish Law on clinical investigations with medical device: Lov nr. 1853 af 09/12/2020 om videnskabsetisk behandling af kliniske afprøvning af medicinsk udstyr

Research Ethics Committees

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.