Medical-scientific research involving human subjects is legally regulated in the Netherlands in the Medical Research Involving Human Subjects Act (WMO). The Quality Assurance Guideline for research involving human subjects describes the requirements that research subject to the WMO in University Medical Centers (UMCs) must comply with. This guideline is written for researchers, coordinators and administrators who are responsible for the quality assurance of research involving human subjects. In addition, it is interesting for everyone involved in the conduct of clinical research in the UMCs.

The guideline addresses, among other things, training, quality system, risk management, contracts, monitoring and auditing. In addition, attention is paid to the DSMB, data management and archiving.

The updated guideline can be found here English / Dutch