Engelsk titel: Research ethics and revised law regarding the Danish Central Scientific Ethical Committee
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Författare:
Kamper-Jörgensen F
Email: fkj@si-folkesundhed.dk
Språk: Dan
Antal referenser: 4
Dokumenttyp:
Översikt
UI-nummer: 04061372
Sammanfattning
Implementation into Danish law of the EU directive on good clinical practice related to drug trials induced a revision of the law-based system of research ethical committees, already in existence since 1992. The first parts of the new legislation were put into effect on 1 June 2003. The more substantial parts of the new law - good clinical practice related to drug trials - will go into effect on 1 May 2004. Based on the new law, there are now common European regulations for the approval and implementation of drug trials. A rigorous handling of applications to the Danish Central Scientific Ethical Committee will be introduced, including a 60-day approval period. Higher levels of protection for people included in trials will be introduced, including more rigorous protection of special vulnerable groups, such as children and people with dementia. Based on counselling by the Central Scientific Ethical Committee, the minister has the authority to introduce a moratorium in certain scientific areas. The basic research ethical committee model has not been changed. It continues to be law-based and rooted in the county system, which also has the responsibility for providing health services, and includes a central appeal provision. The principle of laypeople having a majority of the votes in the committee system (the so-called Danish model) also continues. As of 1 January 2004, jurisdiction was changed from the Ministry of Science, Technology and Innovation to the Ministry of Internal Affairs and Health.