Research Roadmap

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 research projects may only be conducted if the risks and burden for 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 risk of a clinical research project refers, above all, to the risk that the clinical research projects adds above the risk of usual care for patients or the risk of normal daily life for a healthy volunteer. In addition, risk for other current and future patients and society, associated with the scientific quality of the research project must be considered. The researcher is required to estimate these extra risks, which will then be reviewed by the MREC.

To identify the risks of your clinical research project and for drawing up preventive and/or control measures to minimise these risks, you can use 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 at one of the following levels: negligible, moderate or high risk.

Each risk level has specific requirements for participants 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 study protocol, DSMB charter, Monitoring Plan and/or Risk Management Plan.