Risk classification

  • WMO

In order to ensure research involving human subjects is carried out in a manner that is both safe for the participants and guarantees high quality results, the Dutch Federation of University Medical Centers (NFU) has drawn up the Quality Assurance for Research Involving Human Subjects guideline, which has been approved by the deans of the university medical centres.

Article 3 of the Medical Scientific Research (Human Subjects) Act (WMO) states that clinical trials may only be conducted if the risks to and physical demands on participants are minimised, acceptable and proportionate to the anticipated results and advantages of the project. Your weighing of the advantages and disadvantages must be reviewed and authorised by the Medical Research Ethics Committee (MREC). 

The risks of a clinical trial refers first and foremost to the danger that trial procedures will magnify the risk of standard procedures patients are already undergoing, or pose dangerous health risks in daily life for a healthy volunteer. The researcher is required to take into account these extra risks, which will then be reviewed by the MREC.

To classify the risk level of your trial and for drawing up preventive and/or assessment measures to minimise these risks, you can make use of two instruments: Risk assessment Tool (see AMC risicoclassificatie-instrument) and chapter 4 Risk Management of the NFU guidelines for Quality Assurance of research involving human subjects

Based on the probability and severity of all identified risks, the researcher must estimate the overall risk of the research project in one of the following levels: negligible, moderate or high risk.