Tasks

Overseeing the operations of the accredited medical research ethics committees (MRECs)

CCMO is supervisor of the accredited medical research ethics committees (MRECs) in the Netherlands. The supervisory task of CCMO can be divided into three categories: preliminary supervision (such as the assessment of regulations, the expertise and independence of MREC members), for-cause supervision (in response to incidents and reports) and ongoing supervision (quality monitoring).

The law imposes requirements on MRECs wishing to review research protocols for medical research involving human subjects. CCMO examines whether MRECs meet these requirements and can then accredit them. CCMO can set additional guidelines for the working procedures of accredited MRECs. CCMO also assesses the expertise of MREC members. Interested parties can object against these decisions taken by CCMO.

Review Committee

CCMO is also a review committee. The reviewing task of CCMO is limited to specific fields of research as laid down in the Medical Research Involving Human Subjects Act (WMO), the Embryo's Act and the Central Review Decree (Besluit Centrale Beoordeling, BCB). Interested parties can object to decisions taken by CCMO regarding the review of a protocol.

Competent Authority

CCMO acts as competent authority for the (marginal) review of research with a medicinal product. If CCMO is the review committee then the Ministry of Health, Welfare and Sport (VWS) carries out the marginal review. The Ministry of VWS has delegated this task to the Medicines Evaluation Board.

Administrative body that deals with appeals

CCMO functions as administrative body in the case of an administrative appeal against a decision by an MREC.

Registration of medical research with human subjects

CCMO keeps a registration of all research subject to the WMO and the Embryo's Act. This data allows the CCMO to observe information in the area of research with human subjects, embryos and fetuses in the Netherlands. CCMO presents this information in her annual reports. Since the end of 2008 core data from medical research reviewed in the Netherlands by an accredited MREC or CCMO is published in the public CCMO register.

Information

CCMO plays a key role as (inter)national provider of information on medical research with human subjects which is (also) carried out in the Netherlands.