Definition
Medical research is research that aims to answer a question in the field of disease and health (etiology, pathogenesis, signs/symptoms, diagnosis, prevention, outcome or treatment of disease), by systematically collecting and studying data. The research aims to contribute to medical knowledge that is also applicable to populations outside the immediate research population.
Research that falls under the Medical Research Involving Human Subjects Act (WMO) must be tested beforehand by a Medical Research Ethics Committee (MREC). Carrying out research which is subject to the Medical Research Involving Human Subjects Act (WMO) without a positive decision from an accredited MREC/CCMO is an illegal offence and punishable by law.
Decision tools
These will help you decide whether the research should be reported or submitted for review to a MREC:
Research not subject to the WMO
There is not yet agreement on a national review framework for research that is not subject to the WMO. In order to obtain approval from a Board of Directors for conducting the research in the health care institution, a check is made as to whether the protocol is feasible. The following aspects, among others, are then considered:
Does the WMO not apply to your research and is it more related to behavioural science research than medical research? Review the information on the tab social and behavioural sciences.
When is research subject to the WMO?
If the following criteria are met:
Basic principle: there is an infringement of the physical and/or psychological integrity of the subject. The subject himself/herself must be physically involved in the research for the research to be subject to the WMO.
Which research is generally covered by the WMO?
Which research is generally not covered by the WMO?
Which research is generally prohibited by the WMO?
Research with special subjects:
- Children and youngsters under 16
- Incapacitated adults
They are entitled to special protection.
The WMO prohibits research with these subjects, unless:
The CCMO executes the WMO and the Embryo’s Act. Basic principle: protecting subjects taking part in medical research.
In practice the accredited MRECs review the majority of research protocols. The reviewing task of the CCMO is limited to specific fields of research:
In addition to the legal frameworks, there is also a quality standard.
The GCP guideline is an international ethical and scientific quality standard for the design, conduct, recording and reporting of clinical trials involving subject participation.
Compliance with this standard publicly guarantees that the rights, safety and well-being of subjects are protected in accordance with the principles which originate in the Helsinki Declaration (the interest of the patient is always paramount and outweighs the importance of the research),and that the data obtained from clinical trials are reliable.
GCP registration
Researchers conducting or accompanying research which is subject to the WMO should provide a valid registered ICH-GCP certificate prior to commencing the research.
There are two registers:
GCP-WMO
The aim of GCP training courses is to increase the level of knowledge of researchers and research assistants in the Netherlands in the field of clinical research in order to promote subject safety and research integrity. After following GCP training or self-study you can participate in the national GCP-WMO exam. After you pass the exam you will be GCP certified for 4 years and you will be listed in the national GCP-WMO register. For re-registration, a 4-yearly refresher course is required.
The MREC reviews the scientific and medical-ethical acceptability of research protocols and weighs whether the burden on subjects is in balance with the importance of what the researcher wishes to demonstrate with his research.
Both research which is subject and not subject to the WMO will be reviewed. After all, in both cases ethical and medical-scientific requirements must be met, such as: the research has to be meaningful, the subjects have to be well informed, correct anonymisation has to be carried out, data have to be securely stored, etc.
Decisions may only be taken if at least these experts are represented: clinical pharmacologist, pharmacist, lawyer, ethicist, methodologist, subject member.
You can usually choose which accredited MREC you submit your research to for review. Although each MREC itself determines the region it reviews, most of the committees appear to review for the whole of the Netherlands. In Limburg, MREC Zuyderland-Zuyd (MREC Z) and MREC Maastricht UMC+/University are active. Zuyd University of Applied Sciences is a member of MREC Z. Is your research to be conducted within Zuyderland? Then you are obliged to submit it to MREC Z.
To determine by which committee your research should be reviewed, you can use the online tool Committee Finder. Use the filters by clicking on the bar at the bottom of the screen.
Report to MREC or not?
Reporting/submitting procedure
► Your research is subject to the WMO
The research file must meet formal requirements, see the
CCMO standards.
► Your research is not subject to the WMO
Subject information / informed consent
An informed consent should contain the following in understandable language:
Research protocol requirements with regard to subjects
Points to consider when submitting a the research protocol
Data to be provided during, upon completion and after the research
