Research Roadmap

Two types of insurance must be taken out before the start of a clinical trial involving human subjects: WMO clinical trial participants insurance and liability insurance. In certain cases, exemption may be granted for the WMO clinical trial participants insurance. Cover by a liability insurance must always be guaranteed.

People participating in research covered by the Medical Research Involving Human Subjects Act (WMO) must be insured against any potential damages incurred as a result of participating in the study. The insurance must comply with specific regulations stated in the Compulsory Insurance Decree in Medical Research Involving Human Subjects (dd 1-7-2015). Exemption from this insurance obligation is possible under certain conditions. In this case, a request must be included in the submitted application. Even if exemption from the WMO insurance obligation is granted, the liability insurance must still be covered.

If the study is carried out by an 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 WMO human subject insurance or a liability insurance is not needed (section 7, sub 10 WMO).

WMO clinical trial participants insurance

The PIF also contains information about human subject trials subject to WMO regulations. Persons who participate in clinical trials subject to the WMO must be insured to cover any damage caused by the trial. Both locations of Amsterdam UMC have taken out a continuous human subject insurance with Centramed for such WMO studies. This WMO research subject insurance applies to all studies where either location (AMC or VUmc) of Amsterdam UMC is the sponsor. For multicentre research, this insurance therefore also covers research subjects in hospitals and other healthcare institutions who participate in the study, within Netherlands.

If one of both locations of Amsterdam UMC is the sponsor, then registration for the WMO research subject insurance is automatically arranged through the MREC secretariat.

Contact wmo@amsterdamumc.nl if you have any questions, including about potential exemptions.

Note well: if location AMC is the sponsor but the CCMO is the reviewing committee, then first request an insurance statement from wmo@amsterdamumc.nl before you submit your investigation to the review committee. You will receive a temporary statement from the MREC secretariat stating that the WMO insurance has been arranged for this study. However, the insurance cover only becomes effective once the study has been registered with Centramed by the MREC secretariat. This happens when you receive approval from the Executive Board. You will receive a confirmation of this. Check whether you have received the confirmation and if so, whether the given number of research subjects is correct. The confirmation must be included in the research dossier.

For more information see MREC Amsterdam UMC or contact them via 020-4445585 (Monday to Friday between 9.30 and 16.30)

Indemnification

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.

Both locations of Amsterdam UMC have taken out a continuous liability insurance. For more information see MREC Amsterdam UMC of contact them at 020-4445585 (Monday to Friday between 9.30 and 16.30)