As the body responsible for implementing the Medical Research Involving Human Subjects Act (WMO) and the Embryo's Act, the CCMO has a number of legal tasks:
Overseeing the operations of the accredited
medical ethical reviewing committees (MRECs)
The legislation states the obligations of an MREC with regards to reviewing research protocols of medical/scientific research with human subjects. The CCMO checks whether an accredited medical ethical reviewing committee (MREC) meets these obligations (accreditation) and oversees their operations. The CCMO can set up new guidelines with regards to the operations of accredited MRECs. Interested parties can object to the CCMO against decisions that the CCMO has taken regarding the reviewing of a protocol.
The CCMO is also a reviewing committee. The reviewing task of the 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 the CCMO against decisions that the CCMO has taken regarding accreditation of MREC members.
Reviewing research with a medicinal product
From 2019, the National Clinical Trial Office of the CCMO will be the central coordination point in the Netherlands for the implementation of European legislation for reviewing research with a medicinal product. The aim of this legislation is to harmonize the reviewing of research with a medicinal product in the European Union. The National Clinical Trial Office will be responsible for managing a European portal to which research files are submitted, validating research files and allocating dossiers to the competent MRECs, administrative support to the competent MRECs in preparing the assessment report for multinational research for which the Netherlands is reporting Member State (rMS), and coordinating the assessment of safety reports and suspected unexpected serious adverse reactions (SUSARs).
The CCMO acts as competent authority for the (marginal) review of research with a medicinal product. If the CCMO is the reviewing 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.
Three years after the implementation of new European legislation, the competent authority will no longer have a role in reviewing research with a medicinal product. From then on the review of research with a medicinal product will be conducted by the CCMO or the accredited MREC authorised to review the research, supported by the National Clinical Trial Office.
Administrative body that deals with appeals
The CCMO functions as administrative body in the case of an administrative appeal against a decision of an MREC.
Registration of medical research with human subjects
The CCMO keeps an overview of all WMO research reviewed in the Netherlands since the 1st of December 1999. This information allows the CCMO to observe information in the area of research with human subjects. The 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.
As executive body the 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.