Review by the CCMO
The Central Review Decree (Besluit Centrale Beoordeling, BCB) came into force on the 5th of March 1999. Section 1, paragraph a, states the CCMO is the assigned reviewing committee for ‘scientific research whereby genetic material in human body cells are intentionally altered’. The updated BCB of the 3rd of January 2006 has a broader definition of ‘…or the performance of the genetic material is specifically influenced’, to make possible the central review of research with antisense oligonucleotides or RNA interference. This type of research does not fall under gene therapy research.
Furthermore, the updated BCB was altered at Section 1, paragraph 6, to include review of the CCMO of ‘scientific research with a medicinal product for genetically modified organisms’ as intended in Section 1, first paragraph, sub f, of the Decree genetically modified organisms environmental management (Besluit genetisch gemodificeerde organismen milieubeheer, in Dutch). This applies to research whereby genetically modified organisms are administered which to not purposefully alter the genetic material in the body cells of the research subject.
Through the central review of the research as laid down in the BCB, knowledge can be clustered and new insights can be gained into the further developments of these new techniques and the implications they have for society.
More information on the review by the CCMO can be found at Primary submission to the review committee. The WMO offers the CCMO the possibility to extend the review timeline for certain types of research, such as research into gene therapy, with a maximum of 30 days (on top of the timeline of 60 days). The review timeline then amounts to a maximum of 90 days.