Studies involving the observation or interviewing of individuals and or interventions in human subjects, are subject to many laws. One law that always applies is the Personal Data Protection Act(WBP).
Human Subject Act
The very first question is whether the study falls under the Medical Research (Human Subjects) Act (WMO). Not every study falls under the WMO's remit. Details of the assessment criteria that determine whether a study falls under the WMO remit can be found here . If you believe that your study does not fall under the WMO's remit, go to the Medical Ethics Review Committee's pages on non WMO studies to obtain an official statement to confirm the non-WMO status of your project.
Basic regulation and organization of clinical research (eBROK)
In line with national agreements, clinical researchers are required to follow the "Basic regulation and organization of clinical research" (eBROK; www.NFUbrokacademie.nl ) course to obtain the corresponding certificate. The eBROK is only given in Dutch until the third quarter of 2015. An English version of the eBROK is not yet available. It is possible to do the exam in English. More information can be found on the CRB website.
For practical information (such as dates on which the course takes place and registration), you can contact us via the NFU BROK Academy tel. 020-44 44 213 or via info@NFUbrokacademie.nl
In summary the BROK course covers a wide range of legal and organizational aspects of clinical research and includes a national final exam. Researchers who pass this examination are entitled to register in the Dutch national BROK register ( NFU-BROK Register )
Trials involving human subjects
If your project falls under the remit of the WMO and was initiated here at VUmc, you can visit the webpage of the Medical Ethics Review Committee to find out which steps you have to take, and you can also visit the website of the Clinical Research Bureau . There you will find a very practical roadmap for your project, as well as advice and details concerning the obligatory monitoring of your study.
If you are participating in a trial that was not initiated here, you can go directly to the Medical Ethics Review Committee's pages on 'Lokale uitvoerbaarheid' to find out which steps you have to take.
In some instances the Population Screening Act (Wet op het bevolkingsonderzoek, WBO) may be applicable. This Act is intended to protect individuals against screening studies that may pose a danger to their physical or mental health. Projects falling under the WBO's scope must first obtain a license from the Ministry of Health, Welfare and Sport (Volksgezondheid, Welzijn en Sport, VWS) before they can proceed. Such cases do not, therefore, fall under the auspices of the METc. The relevant criteria can be found here.
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The Dutch Personal Data Protection Act (Wet Bescherming Persoonsgegevens, WBP) protects the rights of individual citizens in the Netherlands. The task of monitoring compliance with the laws governing the use of personal data in the hands of the Dutch Data Protection Authority (College Bescherming Persoonsgegevens, CBP). This Act has been translated into a code of conduct known as the Use of Data in Health Research (Code Goed Gedrag), which is used at VUmc. You can find further details here .