Insurances

WMO subject insurance

Proof of a WMO human subject insurance must be submitted to the reviewing committee. Therefore, the sponsor of the study must ensure that such 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.

Exemption from this insurance is possible under certain conditions. If the reviewing committee is of the opinion that there are no risks to the research subjects as a result of participating in the research, then the sponsor can submit a request for exemption (section 7 paragraph 5 WMO). Exemption is also possible 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 (section 7 paragraph 6 WMO). Needless to say, even if exemption from insurance applies, liability insurance must still be arranged.

If the research is conducted by an institution, service or company that is appointed by the Dutch government - for example those under the authorization of the Dutch Ministry of Health, Welfare and Sport or the Ministry of Defence - there is no obligation for a WMO subject insurance (art. 7 sub 10 WMO).

Liability insurance

In principle a liability insurance must be taken out (section 7 paragraph 9 WMO). If the research is conducted by an institution, service or company that is appointed by the Dutch government - for example those under the authorization of the Dutch Ministry of Health, Welfare and Sport or the Ministry of Defence – there is no obligation for a liability insurance (art. 7 sub 10 WMO).