Two insurances
With the introduction of the WMO in 1999, the sponsor of clinical trials became responsible to arrange an insurance that would cover the injury of the research subject caused by the study. Before that time, only a standard medical liability insurance applied.
Before 1999 the research subject had to prove that the investigator has failed, because he or she has acted in violation of the norms resulting from the professional standard that applies to him or her. The research subject also had to demonstrate that there is a causal link between the violated professional norm and the injury.
However, the Dutch government realized that a research subject who participates in a clinical trial contributes in the progress of medical science with no or limited personal interest. The government took the position that the research subject serves society and therefore should not bear the injury that may result from his or her participation in clinical trials. The government decided to set out new rules for indemnity by which the research subject would be compensated also if the injury was not the result of a careless medical professional.
"The research subject insurance is a no fault insurance."
Under the current legislation a research subject insurance is a mandatory. It is a no fault insurance of the risk of an injury as a result of the clinical trial. The research subject insurance is therefore not a liability insurance for the sponsor or medical professional who causes the injury. It is an injury insurance for the research subject. The sponsor of the clinical trial (i.e., company or institute in case of an investigator-initiated trial) must take care of the injury insurance, but the insurance is not concluded in its favor. The sponsor also has no own insured interest.
The research subject is the insured person and claimant and in case of an injury he/she can directly claim at the insurance company without support of the sponsor, institute or investigator. In addition, the insured research subject does not have to show fault or blame in the event of an injury. However, the research subject has to demonstrate that the injury is caused by the research in which he or she was participated (causality).
The liability of the sponsor or investigator on the grounds of careless action is not covered by the research subject (injury) insurance. Therefore, the sponsor or investigator till must have a liability insurance. So for medical research with human subjects both a research subject (injury) insurance and a liability insurance is mandatory.
For the research subject insurance a copy of the insurance certificate has to be included in section G1 of the research file that is submitted to the reviewing committee (i.e., the accredited MREC
or in special case the CCMO). If there are no risks for the research subject or if two standard treatments are compared and the risks of study related procedures are negligible, and the reviewing committee agrees on this, no research subject insurance is required.
For the liability insurance either a copy of the certificate of the liability insurance in section G2 of the research file or a statement in the research declaration that such an insurance is in place suffice in section I2 of the research file.
An exceptional case is when the Dutch government is the sponsor of the medical research. In that case there will be no insurance. Should there be a justified claim, the government will compensate the research subject for the injury.