Immediate annulment of the human subject insurance statement

CCMO has decreed that the submission of a human subject insurance statement to the review committee in the case of a research file is no longer required. This decree comes into effect immediately and applies to new research files yet to be submitted.

The statement allowed the sponsor to clarify whether all human subjects in all participating (Dutch) centres were insured on the basis of WMO (Medical Research Involving Human Subjects Act) human subjects insurance, which party was policyholder and with which insurance company the policy was accommodated. The statement was introduced in July 2015 as a result of the amended Insurance Decree. One of the amendments to the decree concerned the sponsor’s obligation to ensure that all subjects participating in the study were covered by a single insurance contract. Previously, it had also been possible for each participating centre to take out individual subject insurance.

The statement was obligatory as it was not yet clear at the time whether the new insurance certificates would comply with the new obligation in the Insurance Decree. Now, five years later, the insurance certificates usually provide sufficient information. Therefore, CCMO no longer deems the statement necessary. Its annulment reduces the administrative burden, both for sponsor/submitter and review committees.