How does the ethical review process work in Belgium and which are the designated ethics committees?
The European directive 2001/20 has been incorporated in national law by the law dated 7th May 2004 (French version) published in the Belgian Monitor of 18th May 2004. The new legal framework has been in force since 1st May 2004. The law foresees the submission of a dossier for EC review to an ethics committee with “full accreditation.” Should a study be planned to be conducted a a site with an ethics committee without “full accreditation,” review will be refered to an ethics committee with “full accreditation” for review and approval. The Votum will then be refered to the local committee for local compliance and oversight. For multi-center studies, an ethics committee with “full acreditation” will be consulted. For such studies, only a single ethics committee Votum for all sites is required. Selection of the ethics committee is to be undertaken by the sponsor. The Votum will then be refered to the local committee for local compliance and oversight.
Weblinks to Belgian Ethics Commitees.
