G1. Declaration of research participant insurance

As of the 1st of July 2015 the new Insurance Decree (in Dutch) has come into force. This Decree makes it mandatory that the sponsor ensures that any potential damages for all research participants of a research are covered. The Declaration of human subject insurance serves the purpose of clarifying how the sponsor has arranged this insurance.

The new Insurance Decree does not apply to research issued a positive decision by an accredited MREC or the CCMO before the 1st of July 2015, irregardless of any amendments to the research reviewed after this date. The old Insurance Decree applies to those studies.