Research involving human subjects
According to the Medical Research Involving Human Subjects Act (WMO), all medical research on human subjects must be assessed by an ethics committee in advance, either by the Central Committee on Research Involving Human Subjects (CCMO) or an accredited medical ethical reviewing committee (MREC). 
Both observational and interventional medical research is covered by this ethical review obligation, as long as it involves medical research on humans.
The competent committee is only empowered to approve the research protocol if (cf. Section 3 of the WMO):
· it is reasonable to expect that the trial will lead to the advancement of medical science;
· it is reasonable to expect that the advancement could not be achieved without the participation of human subjects or by less radical means;
· it is reasonable to expect that the anticipated benefit to individual subjects and other present or future patients will be proportionate to the risks and burden for subjects;
· the methodology of the trial is to be of the requisite standard;
· the trial is to be performed at suitable institutions and by or under the supervision of persons possessing research expertise, at least one of whom possesses expertise of direct relevance to the procedures involved in the trial in which the subject is to participate;
· it is reasonable to expect that any payment offered to the subject would not be of undue influence upon the decision as to whether consent should be given for the subject’s participation in the trial;
· any payments to be received by the investigator and the institution at which the trial takes place are reasonably commensurate with the nature, scale and purpose of the clinical trial;
· the research protocol clearly indicates the extent of the potential benefits of the clinical trial to the subjects involved in it;
· the research protocol includes suitable criteria for the recruitment of subjects;
· the trial satisfies all other criteria which may reasonably be set for it;
The Code of Conduct for Health Research states the following conditions, regarding the obligation to submit research projects to ethical review:
“Irrespective of other regulations elsewhere, the researcher is obligated to submit a proposed study, which he knows or presumes can lead to questions from the point of view of privacy, to a medical-ethical review committee for assessment. In such a case the project may not be initiated until this committee has given a positive recommendation. Research in which personal data are to be processed must always be submitted to the medical-ethical review committee” (cf. Article 2.12 of the Code of Conduct for Health Research).
Ethical approval, MREC
There are 24 accredited MRECs in the Netherlands that review medical/scientific research applications. The MRECs review the vast majority of all medical research studies. This includes all research involving capable adult subjects. Also, therapeutic research and non-therapeutic observational research with minors and incapacitated subjects fall under their reviewing jurisdiction. The CCMO is the authority where appeals can be submitted against a negative decision by an MREC (CCMO website).
The majority of MRECs are linked to an academic medical centre or a hospital, like e.g. Academisch Ziekenhuis Maastricht / Universiteit Maastricht. Researchers can actually choose which accredited MREC they would like to review their study. Despite each MREC having an assigned geographical region, the majority of them actually review research submitted throughout the whole country. A list of all the MRECs and the definition of the MRECs’ regions can be found under accredited MRECs: http://www.ccmo.nl/en/accredited-mrecs.
Ethical approval, CCMO
CCMO is the responsible body for implementing the Medical Research Involving Human Subjects Act. In addition to e.g. overseeing the operations and obligations of the MRECs, CCMO is also functioning as a reviewing committee within certain fields of research with specific ethical, legal or social aspects and research in fields with limited expertise. The reviewing task of the CCMO is limited to these specific fields of research:
- non-therapeutic interventional research with minors and incapacitated adults;
- research with vaccines (only unauthorised vaccines since the 1st of November 2009);
- research in the field of cell therapy;
- research in the field of gene therapy/medicinal products with GMO (genetically modified organisms);
- research with antisense oligonucleotides;
- research in the field of RNA interference;
- research in the field of xenotransplantation with live animal parts;
- 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 (Embryos Act);
- research with embryos left over after an IVF treatment (leftover embryos)
- invasive observational research on foetuses; (CCMO website; Types of research: http://www.ccmo.nl/en/types-of-research)
Central Committee on Research Involving Human Subjects
Medical Research Involving Human Subjects Act
Central Committee on Research Involving Human Subjects: Reviewing committee: MREC or CCMO? [online]. Available at: <http://www.ccmo.nl/en/reviewing-committee-mrec-or-ccmo?521791aa-1558-489... [Accessed 22 August 2014].
Central Committee on Research Involving Human Subjects: Types of research [online]. Available at: <http://www.ccmo.nl/en/types-of-research> [Accessed 22 August 2014].
The Council of the Federation of Medical Scientific Societies: Code of Conduct for Medical Research, 2004 [pdf]. Available at: <http://www.federa.org/sites/default/files/bijlagen/coreon/code_of_conduc... [Accessed 22 August 2014].
Wright, J. and B. Gordijn, 2005. Medical Research on Human Subjects and RECs in the Netherlands. In: D. Beyleveld, D. Townend, and J. Wright, ed. 2005. Research Ethics Committees, Data Protection and Medical Research in European Countries. Ashgate. pp. 153-162.
 In The Code of Conduct for Health Research, health research is defined as: medical scientific research (such as patient-oriented investigations, epidemiological or health care research) whereby use is made of previously available data or data collected for that purpose, for which professional confidentiality is applicable under Article 88 of the Individual Health Care Professionals Act.