Proof of insurance cover or indemnification

WMO clinical trial participants insurance

Subjects participating in a clinical trial must be insured against any potential damages incurred as a result of participating in the clinical trial. The insurance must comply with specific regulations stated in the Compulsory Insurance Decree in Medical Research Involving Human Subjects (dd 1 July 2015). Exemption from this insurance obligation is possible for low intervention clinical trials. In this case, a request must be included in the submitted application. Even if exemption from the insurance obligation is granted, the liability insurance must still be covered. In general, a common liability insurance policy/policies from the sponsor or investigator(s) is sufficient.

If the research is carried out by a ministerial appointed institution, service or governmental organization, such as those which fall under the Ministry of Health, Welfare and Sport, or the Ministry of Defence, then a human subject insurance or a liability insurance is not needed (section 7, sub 10 WMO). 

Liability insurance

The Dutch Act on medical scientific research with human subjects (WMO, article 7 sub 8-11) outlines rules regarding the liability of the sponsor or the executing party in medical research. These rules apply to all the clinical trials covered by the CTR.

There must be a guarantee that the sponsor or the executing party is capable of fulfilling the responsibilities resulting from liability. This guarantee can emerge from a liability insurance of the sponsor or the executing party. 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.

There is a possibility for the sponsor or executing party liability not to be covered by insurance, but instead for them to guarantee the fulfilment of responsibilities in another manner. Bank guarantees, a blocked third-party account or another form of financial security may be used. This means that a sufficiently solvent sponsor or executing party, for whom there are sufficient guarantees that he can fulfil his obligations, is not required to have insurance or other financial security. This is also the case if the clinical trial 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 – when there is no obligation for a liability insurance (art. 7 sub 10 WMO).