Research Roadmap

Article 3 of the Medical Scientific Research (Human Subjects) Act (WMO) states that medical scientific research may only be conducted if the potential risks and burden for participants are minimized, acceptable and proportionate to the anticipated benefits and scientific value of the study.

In order to ensure research involving human subjects is conducted 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 centers. 

The risk of a study primarily refers to the risk it adds for participants above standard care (patients) or normal daily life (healthy volunteers). In addition, potential risks for other current and future patients, as well as society, must be considered in relation to the scientific quality of the study. The researcher is required to estimate these additional risks, which will then be reviewed by the Medical Research Ethics Committee (MREC).

To identify the potential risks of a study, researchers are advised to consult Chapter 4: Risk Management of the NFU Guideline. This chapter also provides guidance for preventive and/or mitigating measures.

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

Each risk level has specific implications for participant insurance, the intensity of monitoring, and the potential need for a Data Safety Monitoring Board (DSMB). Furthermore, identified risks are used to document risk management and mitigation in e.a. the research protocol, the Monitoring Plan and/or Risk Management Plan and the DSMB charter (if applicable).