[The scientific committee system].
Since 1992 a law based national system of Scientific Ethical Committees has existed. It consists of regional committees supplemented with a Central Committee. The Danish model is characterised by having a majority of lay people in all committees. The law is based on the principle of informed consent. A new law in 2003 will implement the EU directive on Good Clinical Practice. A maximum time of 60 days for the approval of biomedical research projects and approval of multi-centre trials at only one scientific ethical committee will be introduced.
Kamper-Jørgensen
Finn
F
Statens Institut for Folkesundhed, Svanemøllevej 25, DK-2100 København ø. fkj@si-folkesundhed.dk
D002986:Clinical Trials as Topic / Q000331:legislation & jurisprudence; D003718:Denmark; D028741:Ethics Committees, Clinical / Q000331:legislation & jurisprudence / Q000458:organization & administration; D028744:Ethics Committees, Research / Q000331:legislation & jurisprudence / Q000458:organization & administration; D006801:Humans; D007258:Informed Consent / Q000331:legislation & jurisprudence; D035842:Research Subjects / Q000331:legislation & jurisprudence