Review by CCMO
In the case of certain types of research the legislator chose to combine expertise in one single committee. This concerns the review of research with specific ethical, legal or social aspects and research in fields with limited expertise.
The review of these types of research has been appointed to the Central Committee on Research Involving Human Subjects (CCMO) in the Central Review of Medical Research Involving Human Subjects Decree. The reviewing task of the CCMO is limited to a number of specific fields of research:
- non-therapeutic interventional research with subjects under the age of 16 years and incapacitated subjects;
- research with vaccines (only unauthorised vaccines since the 1st of November 2009);
- research on the development of cell therapy;
- research on gene therapy, other products that specifically influence the functioning of the genetic material or a medicinal product with GMO;
- research in the field of xenotransplantation with live animal parts. A moratorium (in Dutch) applies to this type of research;
- research with products that fall under the Opium Act (as part of the treatment for addiction to these products);
- research with human gametes whereby cells taken from human subjects for use in the research are obtained through procedures (for example extracting sperm through a surgical procedure);
- research with human gametes whereby embryos are produced as part of ivf treatment (Embryo Act, in Dutch);
- research with embryos left over of an ivf treatment (leftover embryos) (Embryo Act, in Dutch);
- invasive observational research on fetuses (Embryo Act, in Dutch);
- research in which the condition of the fetus is intentionally altered (Embryo Act, in Dutch).
The CCMO does not charge a fee for reviewing a protocol.
You can submit an objection against a negative decision by the CCMO.
Do you have any complaints with regards to the functioning of the CCMO? The CCMO has a complaints procedure.
The CCMO as reviewing committee prefers digital submission of your files. For this purpose all documents need to be submitted in pdf format on cd-rom, accompanied by a signed cover letter (paper).
It is also allowed to submit your file on paper (unbound, singular). Go to How to submit.