Senest opdateret: 19.08.2010Since 1980 Denmark has had a system of research ethics committees with 11 regional committees and a national committee: The Danish National Committee on Biomedical Research Ethics.
Here you can get further information about:
1. The system of research ethics committees
2. The Danish National Committee on Biomedical Research Ethics
3.EFGCP: "Procedure for the Ethical Review of Protocols for Clinical research Projects in the European Union" - Denmark
1. Concerning the system of research ethics committees
Slightly more than half of the committee members are lay men, appointed by the political system and the other half are medical professionals and active researchers. The system became regulated by law in 1992.
According to Danish law, all research projects in Denmark involving human beings or any kind of human tissue, cells etc. need permission from an regional ethics committee. In the case of medicinal and medicinal devices trial projects a permission from the Danish Medicines Agency is also required before the project can be initiated. In March 2006 the Parlament adopted an act amending the act on a biomedical research ethics committee system: Further access to making clinical trials involving medicinal products on incapacitated trial subjects etc.
See also the departmental circular on the amendment act.
The investigator – not the sponsor - of the research project must apply for permission from the regional research ethics committee for the area in which the investigator is operating. The application should conform with the “Guidelines about notification etc. of a biomedical research project to the committee system on biomedical research ethics”.
The investigator shall use an electronic application form: www.drvk.dk/anmeldelse and send the application on paper aswell. Further information at the regional research ethical committees.
In the case of multi-center trials, the investigator shall only apply for permission from one regional committee, i.e. the regional committee in the area, where the principal investigator carries out the research project. However, in the case of multi-national trial projects, a permission from a Danish committee is always required.
The review of the application by the regional research ethics committee will take place when a complete and valid application has been submitted. A valid application must include the following elements:
- Application form
- The clinical trial protocol
- Subject information and the informed consent procedure
- A lay mens resumé: a short resumé in lay terms.
- all in Danish, including the clinical trial protocol.
Applicants whose project is rejected by the regional ethics committee can appeal the decision at The Danish National Committee on Biomedical Research Ethics.
Further information about the Danish committees can be found in the publication “The Scientific Ethical Committees – Yesterday, Today and Tomorrow”.
2. Concerning The Danish National Committee on Biomedical Research Ethics
Under the
Committee Act, it is the responsibility of the committee system on biomedical research ethics to ensure that from a research ethical point of view, biomedical research projects are carried out in a responsible manner, and that the rights, safety and wellbeing of trial subjects participating in such biomedical research projects are protected, while at the same time possibilities are being created for the development of new, valuable knowledge.
The National Committee consists of 22 members. 4 members, including the chairman, are appointed by the Minister for the Interior and Health, hereby 2 members on the recommendation of the Minister for Science, Technology and Innovation. Furthermore the committee consists of 16 members appointed by the Minister for Health and Prevention on the recommendation of the 9 regional committees - 2 from each regional committee.
Members of The Danish National Committee for Research Ethics:
By the Minister of the Interior and Health:
- Medical director, dr. med. Johs Gaub (chairman)
- Science writer, cand. scient., ph.d. Lone Frank
on the recommendation of the Minister of Science, Technology and Innovation:
- Vacant
- Consultant Diana Ringgaard
Regional members:
- Consultant doctor, associate professor dr. med. MAS Finn E. Nielsen, Capital Region
- Member of the Region Council Nina Berrig, Capital Region (vice chairman)
- Vice Director Inger Marie Bruun-Vierø, Capital Region
- Consultant doctor, associate professorMikael Bitsch, Capital Region
- Member of the Region Council, MPA Ellen A. Thrane, Capital Region
- Consultant doctor, dr. med. Jørgen E. Villumsen, Capital Region
- Member of the Region Council Birgit Tystrup, Capital Region
- Consultant doctor, dr. med. Ebbe Eldrup, Capital Region
- Consultant doctor, associate professor, dr. med. Niels Vidiendal Olsen, Capital Region
- Technician Erik R. Gregersen, Capital Region
- Professor, Consultant doctor, dr. med. Henrik Enghusen Poulsen, Capital Region
- Director Ebbe Saling, Capital Region
- Member of the Region Council Timo Jensen, Region Zealand
- Consultant doctor, dr.med. Knud Rasmussen, Region Zealand
- Consultant doctor, dr.med. Birger Møller, Region Southern Denmark
- Member of the Region Council, Freddie H. Madsen, Region Southern Denmark
- Clinic Manager, Consultant doctor, ph.d. Torben Bæk Hansen, Region Central Jutland
- Natascha Joof, Region Central Jutland
- Consultant doctor, dr. med. Jørgen Aagaard, Region Central Jutland
- Agronomist Jens Ove Keldsen, Region Central Jutland
- Consultant doctor, ph. d. Henrik Krarup, Region North Jutland
- Member of the Region Council, Project Manager Pernille Buhelt, Region North Jutland
The special tasks of the National Committee on Biomedical Research Ethics include:
- coordination of the work in the regional committees,
- laying down guidelines
- giving opinions on issues of a fundamental nature, if this is not related to the approval of a concrete research project,
- acting as an appeals committee in connection with findings in the regional committees and decide on matters where members of the regional committees disagree,
- monitoring 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; and
- considering whether the National Committee on Biomedical Research Ethics is to make recommendations to the Minister for the Interior and Health under Sections 26 and 27 of the Committee Act. These provisions deal with specific, new fields of research.
Moreover, the National Committee provides consultative statements on biomedical research projects planned by Danish researchers for implementation in developing countries.
The Danish National Committee on Biomedical Research publishes each year an annual report in Danish.
3. EFGCP: "Procedure for the Ethical Review of Protocols for Clinical research Projects in the European Union" - Denmark
Read here:
http://www.efgcp.be/Downloads/EFGCPReportFiles/Flow%20Chart%20Denmark%20(revised)%2008-03-01.pdf