G2. Proof of coverage

The new WMO, which came into force on the 1st of July 2012, outlines rules regarding the liability of the sponsor or the executing party in medical research in section 7, paragraphs 8 through 11. These rules apply to all the research projects covered by the WMO.

This means that, in addition to WMO research subject insurance (G1), 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 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 – when there is no obligation for a liability insurance (art. 7 sub 10 WMO).

Multicentre research

A copy of a professional liability insurance certificate will suffice for research with general practitioners. On the Research declaration you can fill in the name of the company that is responsible for proof of insurance coverage under ‘Liability insurance’. If your own centre is responsible then you can choose the option ‘our centre’. Also see: multicentre research.