Denmark - RECs and Medical Research

History

RECs began in Denmark in 1980 as a voluntary system set up by biomedical scientists. Initially it was regulated by the Danish National Committee on Biomedical Research Ethics until 1992 when it came under legal regulation through the Act on the Biomedical Research Ethics Committee System No.402/28.5.92. This Act created a legal framework for the scientific ethical evaluation on biomedical research projects. There are currently 8 regional scientific ethical committees.
There is also an Ethical Advice Committee which is central and gives advice to the public, the Danish Parliament and the Ministry of Health.

Summary of Danish RECs

Type of REC	Central Scientific Committee	Regional scientific ethical committees
Where situated?	Ministry of Research & Information technology	Health regions
Who applies to them?	Issues recommendations to RECs Regulates ethical assessment of multi-centre trials Researchers contesting REC decision	researchers
Formal/Informal	Formal	Formal
National/Regional	National	Regional
Laws Involved (see below)	Act on a Scientific Ethics Committee System No. 402 of 28.5.03 amending the Medicines Act No. 656 of 28.07.95 Law 382 of 28 May 2003 Data Protection Law	Act on a Scientific Ethical Committee SystemNo. 402 of 28.5.03 Law 382 of 28 May 2003 Data Protection Law
Guidance Involved	Declaration of Helsinki	Declaration of Helsinki
Membership requirements	18 members: 2 appointed by each of the regional RECs of which 1 must be MRC appointed and the other not. 2 appointed by the Minister of Research & IT 2 appointed by the Ministry of Health	At least 7 members - 3 nominated by the Danish Medical Research Council County council may increase the membership up to 15 if the workload requires it. The MRC members are active researchers and the remainder have no association to the medical profession They may use consultants for specific expertise
Responsible/accountable to whom?	Independent body. Decisions cannot be brought before other state bodies.	Central Committee
Approval or Advisory powers	Approval	Approval

Not submitting research or failing to follow review

Anyone initiating a project without REC approval and permission from the relevant authorities is punishable by a fine or detention.

Which body, if not the REC itself takes this action, and how do they proceed?

Action may be taken by the patient, the control system within the central committee, the REC and anyone else who informs the police of a breach of the law.

Impact of Directive 2001/20 EC

This will impact in several ways:
Multi-centre trials - a unique opinion is necessary
Time limit - decisions will have to made within 60 days
Protocol evaluation criteria - expert consultation will be necessary in relation to research involving incapable persons

The Directive is partly implemented in Danish law by Law 382 of 28 May 2003, which came into effect on 1 May 2004. The final stage of implementation was completed by Executive Order No. 295 of 26 April 2004.

Legal action that can be taken against RECs

REC decisions may be appealed against to the central committee. An appeal can also be made to the court of appeal but only in the case of wilful neglect or default.

Links section

Danish Medical Research Council (in English & Danish)
Danish Central Scientific Committee (in English & Danish)
Danish Laws (in English & Danish)
News on implementing GCP Directive (English, 29/03/04)

See the REC bibliography section for more links and papers, and the Data Protection Page