Senest opdateret: 24.02.2012Since 1980 Denmark has had a health research ethics committee system. It consists of a national committee and 11 regional committees
Here you can get further information about:
1. The National Committee on Health Research Ethics
2. The system of research ethics committees
1. The National Committee on Health Research Ethics
Under the
Committee Act, it is the responsibility of the committee system on health research ethics to ensure that from a research ethical point of view, health 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 13 members appointed by the minister for health and prevention.
Members of The National Committee for Health Research Ethics:
- Consultant doctor, DMSc Johs Gaub (chairman)
- Professor, LLD Mette Hartlev (vice chairman)
- Professor, consultant doctor, DMSc Raben Rosenberg
- Assistant professor, cand. scient, anth., PhD Nanna Mik-Meyer
- Head of Institute, professor, DMSc Thomas G. Jensen
- Professor, DSc Mads Hermansen
- Professor, Odont, doctor Klaus Gotfredsen
- Head of Institute, professor, MD, PhD Kirsten Ohm Kyvik
- Professor, consultant doctor, DMSc Henrik Enghusen Poulsen
- Consultant doctor, DMSc Knud Rasmussen
- Assistant professor, medical specialist Marie Luise Bisgaard
- Member of the Region Council, law student Natascha Joof
- Member of the Region Council, Project Manager Pernille Buhelt
The special tasks of the National Committee on Health Research Ethics include:
- coordination of activities 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 a board of appeal in connection with findings in the regional committees,
- monitoring the development of research within the health sector and promote 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 Health Research Ethics is to make recommendations to the Minister for the Interior and Health. 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 Health Research Ethics publishes each year an annual report in Danish.
2. The system of health research ethics committees
Slightly more than half of the regional 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.
The investigator and 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 and sponsor shall use an electronic application form: www.drvk.dk/anmeldelse and send the application on email to the competent research ethics committee along with the trial protocol and other information required for the committee's assessment. The email must be send using a digital signature. 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 protocol resumé.
The trial protocol and other information can be received in english with a Danish protocol resumé. Further information at guidelines about notification. Applicants whose project is rejected by the regional ethics committee can appeal the decision at The Danish National Committee on Health Research Ethics.
Further information about the Danish committees can be found in the publication “The Scientific Ethical Committees – Yesterday, Today and Tomorrow”.