Research Roadmap

Research that is subject to the Medical Research Involving Human Subjects Act (WMO) must be covered by two types of insurances (WMO section 7, paragraph 6 and 9): WMO participant insurance and liability insurance. In certain cases, the review committee (MREC or CCMO) may grant an exemption from the WMO participant insurance. A liability insurance must always be taken out. More information is available on the CCMO website.

WMO participant insurance

People participating in research covered by the WMO must be insured against any potential damages incurred as a result of participating in the study. According to the WMO regulations, the IRP contains information about the WMO participant insurance.

Amsterdam UMC has taken out a continuous WMO participant insurance with Centramed, covering all WMO studies with Amsterdam UMC as their sponsor. Certificates can be found on the website of the Local Review Human Research Office of Amsterdam UMC. For multicenter research, this insurance also covers participants in other hospitals and healthcare institutions within the Netherlands. 

If Amsterdam UMC is the sponsor, registration for the WMO participant insurance is automatically arranged through the Local Review Human Research Office. 

For investigator-initiated research with an external Dutch sponsor or a foreign sponsor who cannot provide WMO participant insurance for Dutch study participants, explicit approval from Centramed is required to cover the participants under Amsterdam UMC’s insurance. This approval must be requested via Legal Affairs (jz.secretariaat@amsterdamumc.nl) with the protocol (and ABR form, if available) attached. Proof of approval must be submitted to the review committee (MREC or CCMO) before study approval.
Please note that contacting Legal Affairs should only be done in exceptional cases. As a rule, the external Dutch sponsor or the foreign sponsor is expected to arrange the required insurance themselves.
More information is available on the website of the Local Review Human Research Officeof Amsterdam UMC.

For questions, including about potential exemptions, contact the Local Review Human Research Office via toetsingonderzoek@amsterdamumc.nl  or 020-4445585 (Monday to Thursday between 9.30 and 12.30).

Liability insurance

The WMO (Article 7 sub 8-11) outlines rules regarding the liability of the sponsor or the executing party in medical scientific research. These rules also apply to clinical trials covered by the CTR/MDR/IVDR.
There must be a guarantee that the sponsor or the executing party is capable of fulfilling the responsibilities resulting from liability. This is typically ensured through a liability insurance. Amsterdam UMC has taken out a continuous liability insurance with Centramed.

For more information, consult the website of the Local Review Human Research Office of Amsterdam UMC or contact them via toetsingonderzoek@amsterdamumc.nl  or 020-4445585 (Monday to Thursday between 9.30 and 12.30).