• For research that falls under WMO, the researcher should take out insurance.
• For research that does not fall under WMO, it is not necessary to take out insurance.
The first step is to decide whether insurance for participants is required. In general, for studies involving human participants (WMO) the researcher should take out insurance for the participants. The insurance is taken out in order to cover any damage to the research subjects. This is the so-called direct damage insurance or WMO subject insurance. In addition, a liability insurance must be taken out. For research that falls under the scope of the WMO, two insurances must be provided, namely the WMO subject insurance and liability insurance.
WMO subject insurance
Participants must be insured against any potential damages incurred as a result of participating in the research (website CCMO, http://www.ccmo.nl/). The insurance must comply with specific regulations stated in the Compulsory Insurance Decree in Medical Research Involving Human Participants (dd 1-7-2015). The new Insurance Decree does not apply to research issued a positive decision by an accredited ethical committee or the CCMO before the 1st of July 2015, regardless of any amendments to the research reviewed after this date. Exemption from this insurance obligation is possible under certain conditions. In this case, a request must be included in the submitted application.
A request for exception of the subject insurance can be submitted if:
• there are no risks to the research participants as a result of participating in the research
• in the case of a comparative study of two regular treatment methods if, as a result of the comparative character of the study, the risks are deemed negligible
• if the research is carried out by a ministerially appointed institution, service or governmental organization, such as those which fall under the Ministry of Health, Welfare and Sport, or the Ministry of Defence
Maastricht University covers the WMO participant insurance by a continuous coverage. This means that the included respondents do not need to be signed in per person by the insurance company. Before the end of the year correct numbers of included participants need to be provided to the coordinator insurances at Maastricht University. The principal investigator is responsible for providing this information, which is needed to calculate the premium of the continuous coverage. An overview of costs will be calculated once a year based on the total number of participants and will be administered by the order number of the project (cost € 10,-- excl. 21% BTW per participants).
There is a contact person available at the University. To contact the UM coordinator for queries about the insurances, call (043 38) 82047 or email: UM-Verzekeringen@maastrichtuniversity.nl
In principle liability insurance is mandatory. “Even if exemption from the WMO insurance obligation is granted, the liability insurance must still be covered. The WMO does not state specific requirements to the liability insurance. In general, a common liability insurance policy is sufficient. The insurance must cover the whole research. (CCMO website)”