Consequences of the new Insurance Decree and CCMO Directive External Review as of 1st July 2015
As of the 1st of July a new Insurance Decree and CCMO Directive External Review will come into force. Amongst the changes is the new rule that all research subjects who participate in multicentre research in the Netherlands must be covered by a single research subject insurance. Research applicants are also required to submit a Research subject insurance declaration.
Multicentre research: a single research subject insurance for all participants in the Netherlands
Amongst the significant changes to the Insurance Decree are the scrapping of exclusion criteria which unnecessarily limit the insurance coverage and the change to the premiums which the insurance should cover in order to bring them in line with the prevailing market. Another important change is the new requirement that insurance for all research subjects in the Netherlands who participate in multicentre studies must be covered in a single insurance policy.
The updated decree does not apply to research issued with a positive decision by an accredited METC or the CCMO before the 1st of July 2015, irrespective of any amendments to those studies which have been or will be reviewed after the 1st of July 2015. The Insurance Decree that was in force until the 1st of July 2015 applies to this research.
Update RET 2012 and Research declaration
As a result of the new Insurance Decree the CCMO Directive External Review 2012 (RET 2012) was also updated. As of the 1st of July 2015 it is no longer possible to take out separate research subject insurance for each participating centre. The reference in section 5 sub 2 of the RET 2012 to a research subject insurance per centre has been removed. As a result of this the information on the research subject insurance in the (new) research declaration is also lapsed.
The updated RET 2012 is applicable to new research files submitted after the 1st of July 2015. The new directive does not apply to requests for a further decision on a research protocol which was issued with a positive decision by a reviewing committee before the 1st of July 2015. The CCMO Directive External Review 2012 and its accompanying (old) research declaration, in force until the 1st of July 2015, remains applicable to that research.
New: Research Subject Insurance declaration
Insurance companies will update their policies on the basis of the updated Insurance decree. It is currently not clear whether the new insurance certificates contain sufficient information to be able to determine if they meet the conditions of the new Insurance decree without having to ask the applicant for clarification. To help avoid this the CCMO has added a Research Subject Insurance Declaration to G1 of the standard research file on the website. This declaration allows the sponsor to provide clear information on whether all research subjects who participate in a certain study in the Netherlands are insured, who the policy holder is and which insurance company was used.
In practice, after the 1st of July 2015 it will become evident whether the insurance certificates contain clear enough information on the basis of which the reviewing committee should be able to form a decision. In order to limit the administrative burden, the Research subject insurance decree will lapse when it is proven to be no longer necessary.
Updated Model Insurance text for the patient information (PIF)
The CCMO has also updated the CCMO model for insurance text (which accompanies the patient information, the PIF) to bring it in line with the new Insurance Decree. You can now find the model insurance text patient information for review of studies before 1st of July 2015 (in Dutch) and a model insurance text patient information for review of studies after the 1st of July 2015 (in Dutch).